SCA Pharmaceuticals, Windsor, CT. 483 Issued 11/19/2019

FDA, ORA, HHS, SCA, Pharmaceuticals, Pharmacy, Inspections, 2019, 483

FDA; ORA; HHS; SCA, Pharmaceuticals; Pharmacy; Inspections; 2019, 483;

FDA, HHS, ORA

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Mo ntvale Avenue

10/8/2019-11/ 19/2019*

Sto neham, MA 02 18 0 (781)587-7500 Fax: (781)587-7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOM OUAL TO W HOM REPORT ISSUED
James Milto n Bo yer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windso r, CT 0 6 09 5-1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABU SHMENT INSPECTED
Outsourcing Facility

This document lists observations made by the FDA representative(s) during the inspection ofyotu· facility. They are inspectional observations, and do not represent a final Agency determination regarding yom· compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, con-ective action in response to an observation, you may discuss the objection or action with the FDA representative{s) during the inspection or submit this info,mation to FDA at the address above. Ifyou have any
questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
OBSERVATION 1 There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already disb'ibuted.

Specifically,

The fom failed to adequately investigate the following:

A. There have been seven confomed failures for in-house sterility testing of finished sterile diug

products since October 2018 usingj (6) (~) ~ ethod for detection of fluorescence in

individual microorganisms «6}14)

). All associated batches (1218003930,

1219007440, 1219008117, 1219008696, 1219009160, 1219009289, & 1219012541) were

rejected; however, the investigations did not take into account the identity of the

contaminating microorganism(s) to dete1mine its source. For example:

· Out-of-Specification Laboratory Investigation Repo1t OOS 18-087-W was initiated on 10/15/2018 for the sterility test failure of Buffered Lidocaine 1% in Sodium

Bicarbonate 8.4%[(15) -(~)

yringe lot number 1218003930. The potential root

cause(s) was dete1mined to be human enor; however, the investigation did not

identify the contaminating microorganism(s). The investigation was approved by

Quality Assurance 12/10/2018.

· Out-of-Specification Laboratory Investigation Repo1t OOS 19-049-W was initiated

on 03/22/2019 for the sterility test failure of Buffered Lidocaine 1% in Sodium

Bicarbonate 8.4% !(D) (~)

Syringe lot number 1219007440. A definitive root

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RoOertJ~

X E

RlS:C9lEM'IJ!f

tJ.l&Wlt'I-S 1M9-201912 3501

DATE ISSUED
11/19/ 201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 1of 6 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Mo ntvale Avenue

10/8/2019- 11/ 19/2019*

Sto neham, MA 02 18 0 (781)587- 7500 Fax: (781)587- 7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOM OUAL TO W HOM REPORT ISSUED
James Milto n Bo yer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windso r, CT 0 6 09 5 - 1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABU SHMENT INSPECTED
Outsourcing Facility

cause had not been dete1mined but the Deviation Investigation (DV-19-31 2-W)

indicated the possible root cause was human enor; however, the investigation did not

identify the contaminating microorganism(s). The investigation was approved by

Quality Assurance on 06/17/2019.

· Out-of-Specification Laboratory Investigation Repo1t OOS 19-055-W was initiated

on 04/18/2019 for the sterility test failure of Hydromorphone HCl 0.2mg/mL in 0.9%

Sodium Chloride[(l5) (4)(b) (4

I [(6) (~) bot number

1219008117. The potential root cause identified in Deviation Investigation (DV-19-

385-W) was human enor; however, the investigation did not identify the

contaminating microorganism(s). The investigation was approved by Quality

Assurance on 09/05/2019.
· Out-of-Specification Laborato1y Investigation Repo1t OOS 19-066-W was initiated
on 05/11/2019 for the sterility test failure of Van comycin HCl 1.25g added to 0.9%

Sodium Chloride[(b) (4)

]lot number 1219008696. The

potential root cause identified in Deviation Investigation (DV-1 9-472-W) was human

enor; however, the investigation did not identify the contaminating

microorganism(s) . The investigation was approved by Quality Assurance on

08/05/2019.

· Out-of-Specification Laborato1y Investigation Repo1t OOS 19-071-W was initiated

on 05/28/2019 for the sterility test failure of Glycopyrrolate 0.2mg/mL t5) -(4)

I

Syringe:(6) -C,4) lot number 1219009160. The potential root cause identified in

Deviation Investigation (DV-19-553-W) was human enor; however, the investigation

did not identify the contaminating microorganism(s). The investigation was approved

by Quality Assurance on 08/30/2019.

· Out-of-Specification Laboratory Investigation Repo1t OOS 19-074-W was initiated

on 05/31/2019 for the sterility test failure of Phenylephrine HCl 40mcg/mL in 0.9%

Sodium Chloride[(t5) (4)

!Syringe 6f(4)

lot number 1219009289.

The potential root cause identified in Deviation Investigation (DV-19-554-W) was

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RooertJMalttl ~ROl:>EftJ. Martl"I -S
X Oa1e59'le0 1M ~2019 12JS01

DATE ISSU ED
11/ 1 9/ 201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 2 of 6 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Mo ntvale Avenue

10/8/2019- 11/ 19/2019*

Sto neham, MA 02 18 0 (781)587- 7500 Fax: (781)587- 7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOM OUAL TO W HOM REPORT ISSUED
James Milto n Bo yer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windso r, CT 0 6 09 5 - 1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABU SHMENT INSPECTED
Outsourcing Facility

human eITor; however, the investigation did not identify the contaminating

microorganism(s). The investigation was approved by Quality Assurance on

08/30/2019.

· Out-of-Specification Laboratory Investigation Report OOS 19-123-W was initiated

on 09/25/2019 for the sterility test failure of Phenylephrine HCl l00mcg/mL in 0.9%

Sodium Chloride[(o) (4)

p yringe 1(5) (4)

' ot number 1219012541.

A definitive root cause had not been determined but the Deviation Investigation (DV-

19-810-W) indicated the possible root cause was human errnr; however, the

investigation did not identify the contaminating microorganism(s). The investigation

was approved by Quality Assurance on 10/18/2019.

Fmthermore, it was noted that from January 2019 to October 2019 the firm had

approximately 105 occasions in which Personnel Exit Monitoring had exceeded the action

limit specification for zero objectionable organisms mostly concerning samples taken from

operator hoods (32 occurrences) and chests (50 occmTences); however, the firm had not

identified a potential cause for this trend until the Environmental an d Personnel Monitoring

b) 4)jTrend Report which was approved by Quality on 10/29/2019 during the inspection.

Examples of the objectionable organisms recovered were Bacillus cereus, Staphy lococcus

aureus, Moraxella osloensis, and Roseomonas mucosa.

B. On 08/14/2019 the firm had initiated an Out-of-Specification Investigation Report OOS-19-

111-W for a potency failure for the T90 (90 davs) stability sample of Heoarin Sodium

l0units/mL in 0.9% Sodium ChlorideK0) (4)

hot number

1219008741, result 82%, specificationl(l5) (4 ~%. The OOS result was confirmed and the

firm had initiated a Deviation Investigation (DV-1 9-711 -W) on 08/15/2019 to investigate this

failure. The firm had identified the root cause as inconclusive and took the following
coITective actions: [(6) (4)

. The firm Iia:a not conductectahealth hazard

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RooertJMalttl ~ROl:>EftJ. Martl"I -S
X Oa1e59'le0 1M ~2019 12JS01

DATE ISSU ED
11/ 1 9/ 201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 3 of 6 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Mo ntvale Avenue

10/8/2019- 11/ 19/2019*

Sto neham, MA 02 18 0 (781)587-7500 Fax: (781)587-7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOM OUAL TO W HOM REPORT ISSUED
James Milto n Bo yer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windso r, CT 0 6 09 5-1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABU SHMENT INSPECTED
Outsourcing Facility

evaluation of the sub-potent product nor had they notified the customers who had received

41 !bH

lots

of this

product

with

the

90

day

BUD,

some

of

which

are

cmTently

within

expiry.

C. On 08/16/2019, the fom initiated a Deviation Investigation Repo1t DV-19-716-W to

inYe,_s ·gate leakino within the (5)(4 6 4

assembly (SCA pait# (b) (4)) at the

(b) (4 )side dming (D) (4)

testmg. The fom isolated this leaking (6) (4)to one lot of(b) (41

(lot number (b) (4)

).

This1(b)

(4>1ot

was

used

to

manufactme

41
(b)(

b

atches

of

products

in

which

4 b)(

batches

had

beer6ftirtributed.

The

investigation

indicated

that

the

leaking would occm between 6) 4) The fom concluded that based on investigational

testin9i, sterility testing, successful b 4

testing and risk assessment that the leaking

of the (5}14} (b) <4>had no impact to patient safety; however, the fom had not provided

samples from tnelot of defective (1:5)\41 (b) (4 )Io their vendor for evaluation and

confirmation that the (b) (4)
(I:>) (4J(b) (4) 1t5 4

would function as designed. The manufactmer of the
) had provided a written assessment of the functionality

ofthe(b) <4>on October 21 , 2019 (dming the inspection) without an evaluation of this lot of

defective(b) (4)

D. The Quality Unit failed to adequately investigate consumer complaints by not evaluating retentions samples and retmned product when applicable for confomation of the repo1ted complaint. For example:

· Customer Complaint Fo1m CUS-18-189-W, dated 11/13/2018, indicated that a customer called stating the nmse from the floor was repo1ting more hemonhages on the L&D floor than n01mal. They had five patients in one day hemonhage. The customer was requesting potency data on Oxytocin 20units added to 0.9% Sodium Chloride 1000ml Bag lot number 1218004043. The investigation concluded that there was no impact to product identified as the potency oflot number 1218004043 was confomed to be within specification via batch record review. The fom did not conduct an evaluation of retain samples. The investigation was approved by Quality on 12/27/2018.

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RooertJMalttl
X ~ROl:>EftJ. Martl"I -S Da1eS9'leO 1M ~2019 12JS01

DATE ISSU ED
11/19/ 201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 4 of 6 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Mo ntvale Avenue

10/8/2019- 11/ 19/2019*

Sto neham, MA 02 18 0 (781)587- 7500 Fax: (781)587- 7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOM OUAL TO W HOM REPORT ISSUED
James Milto n Bo yer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windso r, CT 0 6 09 5 - 1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABU SHMENT INSPECTED
Outsourcing Facility

· Customer Complaint Fo1m CUS-19-028-W, dated 2/26/2019, indicated that a customer had administered (bl <41different bags of Oxytocin 20units added to 0.9% Sodium Chloride 500mL Bag lot number 1219006051 to (b) (4)different pregnant patients and in which their ce1vixes did not dilate after receiving this product. The investigation concluded that there was no impact to product identified as the potency of lot number 1219006051 was confomed to be within specification via batch record review. The fum did not conduct an evaluation ofretain samples. On 05/22/2019 the fum receivedi(b) (41units from lot number 1219006051 from their customer. The units were not evaluated but instead were destroyed. The investigation was approved by Quality on 04/03/2019.
· Customer Complaint Fo1m CUS-19-051 -W, dated 04/25/2019, indicated that a customer stated that Oxytocin 20units added to 0.9% Sodium Chloride l000mL Bag lot number 1219007516 was not working on patients. The investigation concluded that there was no impact to product identified as the potency of lot number 1219007516 was confumed to be within specification via batch record review. The fum did not conduct an evaluation of retain samples. The investigation was approved by Quality on 05/20/2019.

Fmthe1more, the fum has had sixteen Out-of-Specification Investigations involving sub-

potent Oxytocin 20 and 30 unit products compounded from October 2018 to March 2019.

Each of these investigations confumed the potency out-of-specification result and the

batches were rejected; however, the above mentioned complaint investigations did not

contain an evaluation of these Out-of-Specification Investigations within the investigation

summary. As a result of these investigations the fum initiated Change Control TCC#19-

073 -W (3/18/2019) to uedate the comeounding_process to (6) (-4 )
I
units (F008446-A-W-02-05y & Oxytocm 30 units (F08544-A-W-02-04)).

J
(Oxytocin 20

OBSERVATION 2

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RooertJMalttl ~ROl:>EftJ. Martl"I -S
X Oa1e59'le0 1M ~2019 12JS01

DATE ISSU ED
11/ 1 9/ 201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 5 of 6 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER

OATE(S) OF INSPECTION

One Montvale Avenue

10/8/2019- 11/ 19/2019*

Stoneham, MA 02 18 0 (781)587- 7500 Fax: (781)587- 7556

FEJNUMBER
3013736415

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
James Milton Boyer, CEO
FIRM NAME
SCA Pharmaceuticals
C ITY. STATE. Z IP CODE. COUNTRY
Windsor, CT 06095 - 1 02 4

STREET ADDRESS
755 Rainbow Rd Ste B
TYPE ESTABUSHMENT INSPECTED
Outsourcing Facility

Each batch of drng product required to be free of objectionable microorganisms is not tested through appropriate laborato1y testing.

Specifically,

l A. The fom failed to adequately_qualify their method for Sterility Testing via[(6) (4 ) in that
during the method transfer, [(6) (4) ]Perfo1mance Qualification for SCA Phaimaceuticals
Windsor, CT (approved 11/28/2017, CT0051 & 01/08/2018, CT0052) the fom did not verify
~l.!J2!·oduct tyQe viaj( b ) (4 ) but instead only conducted testing usin j(b) (4 )

conducted by (bl (4f

analysts. The fom has used this method routinely to test and release sterile dmg product since

[{6f"4)

1.

B. The film's method for sterility testin~(D) (4)
(SOP LAB-020-W), allows for [{6f (4 )
ingredient for sterility testing.

L jProcedure for Sterility Testing ~ (b) (4 ) Iwith the (6) (4)

*DATES OF INSPECTION 10/08/2019(Tue), 10/09/2019(Wed), 10/10/2019(Thu), 10/11/2019(Fri), 10/15/2019(Tue), 10/16/2019(Wed), 10/17/2019(Thu), 10/18/2019(Fri), 11/04/2019(Mon), l 1/05/2019(Tue), 11/06/2019(Wed), 11/07/2019(Thu), l 1/19/2019(Tue)

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE
Robert J Martin, Investigato r

RooertJMalttl ~ROl:>EftJ. Martl"I-S
X Oa1e59'le0 1M ~2019 12JS01

DATE ISSUED
11/ 1 9/201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOlEJE

INSPECTIONAL OBSERVATIONS

PAGE 6 of 6 PAGES
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