DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADDRESS ANO PHONE NUMBER 

One Montval e Aven ue 

St oneham, MA 02180 

(7 81) 58 7- 7500 Fax : (7 81) 58 7- 7556 

ORAPHARM1_ RESPONSES@ fda . hhs . gov 

DATE(S) OF INSPECTION 

1 /30/2023- 3/6/2023* FEJ NUMBER 

3013438665 

NAME A NO Tm E OF INDIVIDUAL TO WHOM REPORT lSSUEO 

De borah E . McHugh, Se n i o r Direc t o r o f Qual ity 

FIRM NAME 

Fres e n ius Kab i Compounding, LLC 

STREET AOORESS 

20 Da n Rd 

CITY. STATE. ZIP CODE. COUNTRY 

Ca nt on, MA 02021- 2809 

TYPE ESTABLISHMENT IN SPECTED 

Outsourc i ng Fac i l ity 

This document lists observations made by the FDA representative(s) dtu-ing the inspection of yotu· facility. They are inspectional 

observations, and do not represent a final Agency determination regarding yotu· 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) dtu-ing the inspection or submit this information to FDA at the adch·ess above. If you have any 

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

DURING AN INSPECTION OF YOUR FIRM I OBSERVED: 

OBSERVATION 1 

Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile 

are not established, written and followed. 

Specifically, on 01/31/2023, production operators were observed perfonning preproduction cleaning of 

the interior of the ISO 5 0 HLFs located in ISO 7 Room 139. During the cleaning operations, multiple 

oeerators were observed leaning their bodies inside the ISO 5 (b){ LFHs in order to clean the interior of the 

)I LFHs. BO leaning inside the ISO 5 '!tiH'LFHs, the operators blocked the path of the unidirectional airflow 

inside the H•LFHs immediately prior to perfonnin!Lproduction operations. Operators then manufactured 

Rocuronium 50mg per 5mL Syrinri, Lot #(6) { 4 j~ ><~LFH # [(6) (4) I; Phenylephrine HCl 20mg 

added to 250mL Bag, L~) (4) in (b)('LFH b) (4 ; Vancomycin HCl 2g added to 500mL Bag, 

Lot # [~(b) ( 4 lf-PLFH b ( 4) ; and N orepinephrine 4mg added to 250mL Bag, Lot #i( b) ( 4 )] in LFH b) (4 . 

OBSERVATION 2 

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established. 

Specifically, the USP <71> method suitability tests perfo1med for your iniectable Vancomycin <lI11g 

products failed to recover Bacillus subtilis demonstrating that theK6) (4) I were not adequately 

neutralizing the antibiotic in order to detect all potential Inicrobial contamination. 

Between June 11 2021, and Janua1y 30, 2023, your fnm used USP <71> to perfo1m sterility testing on 

approximately ft4 batches of your injectable V ancomycin <lI11g products that were distributed for use in 

treating patients. 

EMPLOYEE($) SIGNATURE 

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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 

UEO 

2023 

I of2 PAGES 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

D ISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION 

One Montvale Avenue 1 /30/2023- 3/6/2023* 

St oneham, MA 02180 FEJ NUMBER 

3013438665 (781)587- 7500 Fax : (781)587- 7556 

ORAPHARM1_ RESPONSES@fda . hhs . gov 

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT lSSUEO 

Deborah E. McHugh, Senior Direc t o r of Quality 

FIRM NAME STREET AOORESS 

Fresenius Kabi Compounding, LLC 20 Dan Rd 

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED 

Cant on, MA 02021- 2809 Out sour cing Facility 

*DATES OF INSPECTION 

1/30/2023(Mon), 1/31/2023(Tue ), 2/01/2023(Wed), 2/02/2023(Thu), 2/06/2023(Mon), 2/07 /2023(Tue ), 

2/08/2023(Wed), 2/09/2023(Thu), 2/13/2023(Mon), 2/14/2023(Tue), 2/15/2023(Wed), 2/16/2023(Thu), 

2/27 /2023(Mon), 3/06/2023(Mon) 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE($) SIGNATURE 

Jonathan G Matr isciano, Investigator 

DATE lSSUEO 

3/6/2023 

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 2 of2 PAGES 
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."