DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER 

1 58- 1 5 Liberty Avenue 

Jamaica, NY 11433 

(718) 3 40- 7000 Ext:5301 Fax: (718)662- 5661 

ORAPHARM1_ RESPONSES@fda.hhs.gov 

OATE(S) OF INSPECTION 

2/14 /2023- 3/9/2023* FEJNUMBER 

3015468054 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Snapper D. Romano, Interim Co- Direct or Pharmacy 

FIRM NAME 

Maimonides Medical Center - Pharmacy 

STREET ADDRESS 

4802 10t h Ave 

CITY. STATE. ZIP CODE. COUITTRY 

Brooklyn, NY 11219- 2916 

TYPE ESTABUSHMENT INSPECTED 

Producer of Sterile and Non- Sterile Drug 

Products 

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional 

observations, and do not represent a final Agency detemiination regarding your compliance. If you have an objection regarding an 

observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or 

action with the FDA representative{s) during the inspection or submit this infonnation to FDA at the address above. If you have any 

questions, please contact FDA at the phone number and address above. 

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: 

OBSERVATION 1 

Your facility design allowed the influx of poor quality air into a higher classified area. 

Specifically, the Emergency Department (ED) Satellite Phaimacy unclassified "segregated 

compounding area" lacks adequate controls to ensure that an acceptable environment is maintained in 

and around the ISO 5 ~N_] J laminai· flow hood to produce sterile drngs for in-patient use. The ED 

ISO s(b) ( 4) laminar flow hood is used to produce sterile drngs for in-patient immediate use 

includm~ Amikacin Injectable (Equiv to: Amikin) 1000 mg/100 ml NS, Order #~D) (6), (D) (?)(Ct 

MRN: 5 ~l>l f.l6f(1J(Cl observed prepai·ed on 02/17/2023 at 1215, Expi1y: 02/18/2023 at 0020. The following 

objectionable conditions were observed in the ED Satellite Pha1macy: 

a. An air-conditioner cassette with local manual temperature and fan speed control is fitted in the 

ceiling of the room above and adjacent to the ISO 5 [(b) ( 4) !laminar flow hood. You have not 

demonstrated that air delivered by the air-conditioner does not enter the ISO ~(b) ( 4 I laminar 

flow hood. 

b. The air-conditioner cassette is located directly above the counter where components for sterile diugs 

are staged and[(6) (4) ] disinfected for entiy to the ISO 5 horizontal laminar flow hood. You do not 

have adequate conti·ols to prevent contamination of the surfaces of diug components staged and 

[(b) ( 4) I disinfected directly beneath the air-conditioner cassette to avoid introduction of 

contaminants into the ISO 5 ((b) ( 4) I laminar flow hood where aseptic operations are to be 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Edmund F Mrak, I nvestigat or 

-·

-- 3/9/2023 

OF THIS PAGE Victoria Spivak, I nvestigat or 81;1'led8'/: E«ru'ISF ..... .lf-S 

Karishma G Gopaul, I nvestigat or ffl ~ 

-

0~3l23 

X 

FORM FDA ~83 (09/08) PAGE I of3 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

1 58- 1 5 Liberty Avenue 2/1 4 /2023- 3/9/2023* 

Jamaica, NY 11433 FEJNUMBER 

301 5468054 (71 8) 3 40- 7000 Ext : 5301 Fax : (71 8)662- 5661 

ORAPHARM1_ RESPONSES@fda . hhs . gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Snapper D. Romano, Interim Co- Direct or Pharmacy 

FIRM NAME STREET ADDRESS 

Maimonides Medical Center - Pharmacy 4802 1 0t h Ave 

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED 

Brooklyn, NY 1121 9- 291 6 Producer of Sterile and Non- Sterile Drug 

Products 

perfo1med. 

C. The air-conditioner cassette is located directly above the counter where personnel don sterile gloves 

for aseptic operations in the ISO 5.(l5) (4 ) I laminar flow hood. 

d. During the inspection on 02/14/2023 a buildup of dust and debris was observed in the air flow path 

on the fins of the air-conditioner cassette. 

e. You reuse the disposable non-sterile frocks, donned for aseptic operations in the ISO 5 ((l5) -(4) I 

laminar flow hood, during an [(b ) ( 4) I shift and store such frocks for reuse under unclassified 

conditions. 

f. During the inspection on 02/14/2023 a mop used for cleaning and sanitizing the floor in the ED 

satellite pha1macy was observed improperly stored and leaning on the wall near the ISO 5 [(l5) (4) I 

laminar flow hood. 

OBSERVATION 2 

Sinks or drains were present in the cleamoom where the ISO 5 classified aseptic processing area was 

located. 

Specifically, in the Medical Intensive Care Unit (MIClJ) satellite phaimacy unclassified "segregated 

compounding ai·ea" a sink with water supply is located approximately 1.2 meters (just outside the line of 

demai·cation) from the ISO 5 [(l5) (4) !laminar flow hood. The MICU ISO 5 [{ITT (4) !laminar flow 

hood is used to produce sterile diugs with a 12-hour BUD for in-patient use. During the inspection on 

02/15/2023 we observed the phaimacist using the sink within the MICU to wash his hands as paii of the 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Edmund F Mrak, I nvestigat or 3/9/2023 

OF THIS PAGE Victoria Spivak, I nvestigat or -· ffl 81;1'led8'/

--: -E«ru'ISF ..... .lf-S 

Karishma G Gopaul, I nvestigat or ~ 0~3l23 

X 

of3 FORM FDA ~83 (09/08) PAGE 2 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
-·- 81;1'led8'/

--: E«ru'ISF ..... .lf-S ffl ~ 0~3l23 

X 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

1 58- 1 5 Liberty Avenue 2/1 4 /2023- 3/9/2023* 

Jamaica, NY 11433 FEJNUMBER 

301 5468054 (71 8) 3 40- 7000 Ext:5301 Fax: (71 8)662- 5661 

ORAPHARM1_ RESPONSES@fda . hhs . gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Snapper D. Romano, I nterim Co- Direct or Pharmacy 

FIRM NAME STREET ADDRESS 

Maimonides Medical Center - Pharmacy 4802 1 0t h Ave 

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED 

Brooklyn, NY 1121 9- 291 6 Producer of Sterile and Non- Sterile Drug 

Product s 

personnel gowning process before perfonning aseptic operations in the ISO ~(6) (~) I laminar flow 

hood to J)roduce Phenylephrine Injection (Equiv to: Neo-Synephrine NS 100 mg/250 ml), Order # 

~t>f (6 , (6J (7J(Ct MRN: 5 fbl( f.ltif(7)(cl prepared on 02/15/2023 at 1515, Expi1y : 02/16/2023 at 0315. 

*DATES OF INSPECTION 

2/14/2023(Tue), 2/15/2023(Wed), 2/16/2023(Thu), 2/17/2023(Fri), 3/08/2023(Wed), 3/09/2023(Thu) 

Victoria Spivak Karish'na G Gopaul 

~~Victorias · -S ;;~re; Kariwna G. ~-S X Date Signed: 03-09--~0:15:55 X Date Sijgned: ~2023 1 :17:14 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Edmund F Mrak, I nvestigat or 

Victoria Spivak, I nvestigat or 

Karishma G Gopaul, I nvestigat or 

DATE ISSUED 

3/9/2023 

FORM FDA ~83 (09/08) PAGE 3 of3 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
 

The observations of objectionable conditions and practices listed on the front of this form 

are reported: 

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 

2. To assist firms inspected in complying with the Acts and regulations enforced by the 

Food and Drug Administration. 

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: 

"Upon completion of any such inspection of a factory, warehouse, consulting 

laboratory, or other establishment, and prior to leaving the premises, the officer or 

employee making the inspection shall give to the owner, operator, or agent in charge a 

report in writing setting forth any conditions or practices observed by him which, in his 

judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) 

consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has 

been prepared, packed, or held under insanitary conditions whereby it may have become 

contaminated with filth, or whereby it may have been rendered injurious to health. A copy 

of such report shall be sent promptly to the Secretary."