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