Denver Solutions, LLC dba Leiter’s Health, Englewood, CO. 483 issued 07/18/2019

FEI, 3013438582, FDA, HHS, ORA, 2019, 483, Denver, Solutuons, Leiters, Health

FEI, 3013438582; FDA, HHS; ORA; 2019, 483; Denver, Solutuons; Leiters, Health;

FDA, ORA, HHS

Denver508ed 
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER

DAT E(S) OF INSPECTION

6th & Kipl i n g St. (P . 0 . Bo x 2 5 08 7 )
De nver, co 80225 - 008 7
(303 )236-3000 Fax: (303 )236-3100

7/ 1 /201 9- 7/ 18/201 9*
FEJ NUMBER
3 013 43 8 5 82

NAME A NO TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Chri s t opher F. Zuccare ll i, Chief Operatin g Offi c er

FIRM NAME

STREET AOORESS

De nver Solutions , LLC DBA Leiter' s Heal th
C ITY. STAT E. Z IP CODE. COUNTRY
Englewood, co 80112-714 5

137 96 Compark Bl vd
TYPE ESTABLISHMENT INSPECTED
Out sourc i ng Fac i l ity

This document lists observations made by the FDA representative(s) dtu-ing the inspection ofyotu· facility. They are inspectional observations, and do not represent a final Agency detennination regarding your compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative{s) dtu-ing the inspection or submit this infonnation to FDA at the address above. Ifyou have any questions, please contact FDA at the phone ntunber and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
OBSERVATION 1 Aseptic processing areas are deficient in that walls are not smooth and/or hard surfaces that are easily cleanable.

Specifically,

On 7/ 1/19, I observed cracks and chips on the ac1ylic view screens od5TT4>rso 5 laminar flow hoods

located in Room 195, where(D) (4)

loccurs. The crack in Hood (b)(41appeared to be 5-

inches in length spreading horizontally along the view screen above the sterile compounding work

space. A thick and uneven bead of silicone caulk was used to repair the crack on an unknown date -

there were no maintenance records for the repair. The crack and uneven caulk surface is not smooth or

hard and therefore may be difficult to disinfect and sanitize.

In addition, your ISO 5 cleaning procedure (SOP 4.400 DEN) does not address cleaning the inside of the ac1ylic view screens and front surfaces, within the ISO 5 laminar air flow space where sterile air contacts and passes as it flows down to the compounding work space. On 7/8/19, I observed the ISO 5 laminar flow hood cleaning process and noted the inside of the front view screen and front surfaces were not cleaned prior to compounding.
The following mugs products were compounded in Hood(bl (4 etween 4/1 5/19 and 7/5/19:

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EMPLOYEE($) SIGNATURE
Zachery L Miller,

Inve stigato r

=.~-.,,. ~LllleJ

X

sqieo 01-1

19 1s2,os

DAT E lSSUEO
7/ 18/201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOLETE

INSPECTIONAL OBSERVATIONS

PAGE 1of 3 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER

DATE(S) OF INSPECTION

6th & Kipling St. (P.O. Box 25087)

7/1 /201 9- 7/18/201 9*

Denver, CO 80225 - 0087 (303)236-3000 Fax: (303)236-3100

FEJ NUMBER
3013438582

NAME ANO TITLE OF INDIVIDUAL TO W HOM REPORT ISSUED

Christopher F. Zuccarelli, Chief Operating Officer

FIRM NAME

STREET AOORESS

Denver Solutions, LLC DBA Leiter' s Health
C ITY. STATE. Z IP CODE. COUNTRY

13796 Compark Blvd
TYPE ESTABLISHMENT INSPECTED

Englewood, CO 8011 2 -7 1 4 5

Out sourcing Facility

-
DOM

-
PRODUCT DESCRIPTION

4/15/2019 Neosti ine Meth !sulfate 1 mglml ln'ection

4/16/2019 Rocuronium Bromide (10 mg/ml) (lnjection)S ml in 5 ml

4/17/2019 Neostigmine Methylsuffate (1 mg/ml) (Injection) 4 ml in a 5 ml Syringe

4/17/2019 Atro ine Sulfate 0.4 m ml 1n·ection 2.5 ml in a 3 ml S rin e

4/18/2019 Succinylcholine Chloride (20 mg/ml) (Inject ion) 7 ml in a 10 ml Syringe

4/18/2019 Phenylephrine HCI 100 mcg/ml (0.1 mg/ml) in 0.9% Sodium Chloride (Injection) 5ml in a 5ml Syringe

4/22/2019 Succinylcholine Ch loride (20 mg/m l ) (Inject ion 7ml in a 10ml Syringe

4/30/2019 Sta bility Batch of Tropicamide 1% - PHENYleph rine HCI 2.5% in Sterile Water for Injection, Ophthalmic Solut ion, 2 ml in an 11 ml Dropper Bottle

5/1/2019 Phen ephrine HCI 100 mcg/ml (0.1 mg/ml) in 0.9% Sodium Chloride {Injection) 10ml in a 10ml Syringe

5/2/2019 Lidocaine HCI 2% (20 mg/ml ) (Injection) PF 3 ml in a 3 ml Syringe

5/6/2019 Neostigmine Methylsulfate (1 mg/ml) (Injection) 5 ml in a 5 ml Syringe

5/13/2019 Midazolam HCI 5 mg/ml (Injection) 30 ml in a 35 rnlSyrlnge

6/17/2019 6/19/2019 7/9/2019 Ketam ine HCI 10 m ml 5 ml in a 5 ml S rin
ITEM2
You compound mugs that are essentially a copy of one or more approved mugs within the meaning of sections 503B(a)(5) and 503B(d)(2).
Specifically, you compound mug products that: a) are identical or nearly identical to an approved mug that is not on the mug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing; or b) are not identical or nearly identical to an approved mug, but contain a bulk mug substance that is also a component of an approved mug, and for which there is no change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded mug and the comparable approved mug.

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EMPLOYEE($) SIGNATURE
Zachery L Miller,

Investigator

zacne,y L Mlef
X O h ~ ~zactlefYL~-$3 07-18-2019 1S2105

DATE lSSUEO
7/18/201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOLETE

INSPECTIONAL OBSERVATIONS

PAGE 2 of 3 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER

DATE(S) OF INSPECTION

6th & Kipling St. (P . O. Box 25087)

7/1 /201 9- 7/18/201 9*

Denve r, CO 80225 - 0087 (303)236- 3000 Fax: (303)236- 3100

FEJ NUMBER
3013438582

NAME ANO TITLE OF INDIVIDUAL TO W HOM REPORT ISSUED

Christopher F. Zuccarelli, Chief Operating Officer

F IRM NAME

STREET AOORESS

Denve r Solutions, LLC DBA Leiter' s Health
C ITY. STATE. Z IP CODE. COUNTRY

13796 Compark Blvd
TYPE ESTABLISHMENT INSPECTED

Englewood, CO 8011 2 - 7 1 4 5

Out sour cing Facility

Examples of compounded chug products that are essentially a copy of one or more approved chugs include: 1) Glycopynolate 0.4 mg per 2 mL, 2) Neostigmine methylsulfate 4 mg per 4 mL, an d 3) Succinylcholine chloride 140 mg per 7 mL

*DATES OF INSPECTION 7/01/2019(Mon), 7/02/2019(Tue), 7/03/2019(Wed), 7/08/2019(Mon), 7/09/2019(Tue), 7/12/2019(Fri), 7/15/2019(Mon), 7/16/2019(Tue), 7/17/2019(Wed), 7/18/2019(Thu)

SEE REVERSE OF THIS PAGE

EMPLOYEE($) SIGNATURE
Zachery L Miller, Investigator

zacne,y LMlef
X O h ~ ~zactlefY L ~-$3 07-18-2019 1S2105

DATE lSSUEO
7/18/201 9

FORM FDA 483 (09/08)

PREVIOUS EDmON OBSOLETE

INSPECTIONAL OBSERVATIONS

PAGE 3 of 3 PAGES
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