DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER 

FDA/CBER/OCBQ/Division of Manufacturing and Product Quality 

10903 New Hampshire Avenue, Silver Spring, MD 20993 

Attention: Jay Eltennann, Building 71, Room 6038 

Telephone: (240) 402-9168 

Industry lnfonnation: www.fdagov/oc/industry 

DATE($) OF INSPECTION 

June 15 -19, 2020 

FEINUMBER 

301543430[ 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: John Mosack,VP Manufacturing/General Manager, Catalent Maryland Harrnans (BWl) 

FIRM NAME 

Paragon Gene Therapy/Catalent Maryland Inc. 

STREET ADDRESS 

7555 Hannans Road 

CITY, STATE ANO ZIP CODE 

Hannans, Maryland, 21077 

TYPE OF ESTABLISHMENT INSPECTED 

Biologics/Cell Therapy Manufacturer 

THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE($) 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 PL.AN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE 

OBJECTION OR ACTION WITH THE FDA REPRESENTATIVE(~) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF 

YOU HAVt: ANY QUESTIONS, PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESS ABOVE. 

DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED: 

l. Standard operating procedures (SOPs) are not always followed. Specifically; 

a. Manufacturing personnel do not follow SOP 05.0066, Aseptic Techniques Used for (b) (

4) in the 

Biological Safety Cabinets (Revision 07., Effective Date Feb 21. 2020). During the observation of the filling 

simulation for the (b) (4) (b) (4) (b) (4) into (b) (

4) on June 18, 2020, the operator working 

outside the Class Cb><•>{IsG"'1

' 

1

Grade 11> 11'Biological Safetv Cabinet was not wearing the required sterile sleeves. 

Additionally, the operator was handing off the (b) (

4) and crossing over the Biological Safety Cabinet barrier to 

the operator working inside the Biological Safety Cabinet. 

b. Twenty-two deviations were initiated in 2019 and 2020 due to environmental monitoring and personnel 4 41 monitoring excursions that occurred during (b) (4) in the Class (bH >

1

1sd'll~Grade(bll 8iological Safety 1 

Cabinet in Suite (bH• rhe firm attributed the root cause ofthese deviations to personnel failing to follow SOP 

05.0066, Aseptic Techniques Used for (

6) (4) in the Biological Safety Cabinets. The three CAPAs 

initiated did not provide assurance that the environmental and personnel monitoring issue is resolved. 

c. Eight deviations were initiated in 2019 because the written procedure for SOP BWJ 04.042, Cleaning of GMP 

Manufacturing Clean Rooms (Revision 03, Effective Date Apr 17, 2020) and SOP 05.0087, Good Housekeeping 

Guidelines (Revision 08, Effective Date Apr I 0, 2020) was not always followed. 

d. Fifty deviations were initiated from April 2019 to May 2020 because the written procedure for SOP 05.0013, 

Good Documentation Proctices (Revi~ion 11, Effective Date June 14, 2020) was not always followed. 

e. Twelve deviation investigations were not completed within 30 days as stipulated in SOP 05.0240, Event, 

Deviation and Investigation Management in (o) (4) ~Revision 02, Effective Date Sep 17, 2019) and remained 

open for one day to 71 days after the 30-day target. There was no documentation ofextension or approval ofan 

extension before closure per SOP 05.0240. 

f. Ten legacy deviation investigations that were not completed within 45 days as stipulated in SOP 05.1033, 

Legacy Deviation Management and (o) (4) Business Continuity (Revision 01, Effective Date Apr 17, 2020) 

and remained open for eight days to 89 days after the 45-day target. There is no documentation of extension or 

approval ofan extension before closure per SOP 05. l 033. 

EMPLOYEE($) NAME AND TITLE (Print or Type) 

Priscilla M. Pastrana. CSO, Lead Inspector 

Wanda E. Pagan, Ph.D., Biologist, 

Andrew Byrnes, Ph.D.. Supv. Res. Microbiologist 

and Bo Liang, Ph.D.,Visiting Associate 

DATE ISSUED 

06/19/2020 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page 1 of 2 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

FDA/CBER/OCBQ/Division of Manufacturing and Product Quality June 15 -19, 2020 l 0903 New Hampshire A venue, Silver Spring, MD 20993 

Attention: Jay Eltermann, Building 71, Room 6038 FEI NUMBER 

Telephone: (240) 402-9168 

3015434301 Industry Information: www.fda.gov/odindustry 

NAME AND TITLE OF INDIVIDUAL TO w-lOM REPORT IS ISSUED 

TO: John Mosack, VP Manufacturing/General Manager, Catalent Maryland Harmans (BWI) 

FIRM NAME STREET ADDRESS 

Paragon Gene Therapy/Cata lent Maryland Inc. 7555 Hannans Road 

CITY. STATE ANO ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Harmans, Maryland, 21077 Biologics/Cell Therapy Manufacturer 

2. Inadequate review and trending ofdeviation investigations. Specifically: 

a. The lnvestigational Review Ro11rd only reviews the major deviations. There is no oversight or review of minor 

deviations. 

b. Only trending ofclosed deviations is conducted as stipulated in SOP 02.0029, Trending of Deviations 

(Revision 07, Effective Sep 09, 2019.) The firm does not conduct the trending ofopen deviations. 

3. Inadequate controls for the prevention of mix-up of materials. Specifically; 

Incorrect materials with similar/identical names were inadvertently used in the manufacturing of (6) (4) -

(b) (

4) For exany,le, in Deviation #DV-B-0086, (b) (4) (b) (4) should be 

used for the preparation ofthe (b) (4) However, (b) (

4) (b) (4) was used, 

leading to termination of (b) (4) lots. Although a CAPA was initiated, there was no effectiveness check. 

Similar incidents with other materials and reagents ( (6) (4) ~-----. (b) (

4 I )

(b) (

4) ) have also been documented in subsequent deviations. 

I 4. Measures to prevent the recurrence of cracks and leaking in cell culture vessels used for ~~ 

(b) (4) are inadequate. Specifically, 12 deviations related to cracks and leaking in (b) (

4) 

(b) (4) have been documented. Although a Supplier Corrective Action Report (SCAR) has been initiated 

with Deviation# DV-B-0011, no follow-up with suppliers has been conducted. 

5. The expiration dates ofmedia that are (b) ( 4

) for the manufacturing of 

(b) (

4) (b) (4) are not set and documented. Spccificall , (b) types of (b) (4) media 

for (b) (4) (b) (4) are (b) (4) foll~~ing established SOPs, no 

expiration dates are set prior to being released for product manufacturing or documented in the batch record. 

EMPLOYEE($) SIGl'JATI 1~i: EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 

SEE Priscilla M. Pastrana, CSO. Lead lnspector REVERSE 

OF Wanda E. Pagan, Ph.D., Biologist, THIS 06/19/2020 PAGE Isl Andrew Byrnes, Ph.D.• Supv. Res. Microbiologist

and Bo Liang, Ph.D.,Visiting Associate 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page 2 of2 
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)