DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NLJMBER 

FDA/CBER/OCBQ/Dl'vlPQ 

I0903 New Hnmpshire Avenue, Silver Spring, .MD 20993

Atteation: Carolyn Renshaw, Building 71 Room 4042 

Telephone: 240.402.7343 

Industry Information: www.fda.gov/oc/industry 

DATE(S) OF INSPECTION 

03/06/23-03/I 0/23 

l"E:I NUMBER 

3015434301 

NAME AND TITLE OF INDIVIDUAL TO WI-IOM REPORT IS ISSUED 

TO: Joe Torres, VP Operations, Cell Gene & Therapy and Biologics Drug 

FIRM NAME 

Catalent Maryland, Inc. 

STREET ADDRESS 

7555 Harmans Road 

CITY, STATE AND ZIP CODE 

Harmans, MD 20177 

1YPE OF ESTABLISHMENT INSPECTED 

Drug Substance Manufacture 

THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(SJ DURING THE INSPECTION OF YOUR FACILITY, THEY ARE INSPECTIONAL OBSERVATIONS; AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU 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) DURING n-lE INSPECTION OR SUBMIT THIS INFORMATION 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 (I) (WE) OBSERVED: 

1. Your Quality Unit failed to ensure the integrity and effectiveness of the Quality Management system. 

Specifically, 

Change controls are not scientifically justified and do not include a sufficient analysis of the impact ofthe change

by the Quality Unit as delineated in standard operating procedure (15} (41 Change Control Management t5 (4)

(15) (4) effective 01/28/2022. In 03/23/2022. RP-9001 Lot# {15) (4) was~ ared 

utili.zin (b) (4) rather than (b) (4) ~ -=-=----

(b) (4) and (b 4) m substance batch record was signed offfor release by the quality unit on 03/06/2023. 

Change control (15) (4 covering the change, was not approved by the Quality Unit prior to release of the lot. 

2. The Quality Unit failed to address issues that have the potential to impact the quality of the product. 

Specifically, 

The Quality Unit did not follow the SOP Deviations, which requires (15) 4) ,.;....;.---- oJ (4) 

as agreed upon the Quality Unit and subject matter experts. The 

(b) (4) - -ep-o-rt~H~ar- mans (BWI) Facility (6J (41 approved 03/01/2023,

does not include -......!:======1.......:..-.(6) (4J 

SEE 

REVERSE 

OF THIS 

PAGE 

/s/ /s/

[]ATE 

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ISSUED 

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FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS ~'\ ,\ Page 1 of 1 
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 judgement, 

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." 

FORM FDA 483 (9/08)