Overview
- 28 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
28
Form 483s
12
EIRs
13
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 26 Sep 2025 | Human Drugs | 483 | View 483 → |
| 21 Nov 2024 – 27 Nov 2024 | Biologics | Clean | |
| 15 May 2024 – 24 May 2024 | Human Drugs | 483 | View 483 → |
| 20 Feb 2024 – 23 Feb 2024 | Biologics | 483 | View 483 → |
| 26 Jul 2022 – 4 Aug 2022 | Biologics | 483 | View 483 → |
| 11 Apr 2022 – 15 Apr 2022 | Biologics | Clean | |
| 8 Nov 2021 – 12 Nov 2021 | Human Drugs | Clean | |
| 10 Aug 2020 – 14 Aug 2020 | Human Drugs | 483 | On file |
| 13 May 2019 – 17 May 2019 | Human Drugs | Clean | |
| 11 Jul 2018 – 17 Jul 2018 | Biologics | 483 | On file |
| 26 Mar 2018 – 28 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 17 Apr 2017 – 20 Apr 2017 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Sonya M Edmonds, Nicole E Knowlton, David A Acevedo Santana
24 May 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Saundrea A Munroe, Zhong Li, Melanie M Walker
24 May 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saundrea A Munroe, Zhong Li, Melanie M Walker
24 May 2024
21 CFR 211.192
Written record of investigation incomplete
Cited by Saundrea A Munroe, Zhong Li, Melanie M Walker
24 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saundrea A Munroe, Zhong Li, Melanie M Walker
Investigators
FDA investigators tied to this site in the record.
Seneca D Toms3 insp.
Penny H Mccarver3 insp.
Jason F Chancey2 insp.
Sonya M Edmonds1 insp.
Nicole E Knowlton1 insp.
David A Acevedo Santana1 insp.
Viviana R Ramirez1 insp.
Shaina R Fullwood1 insp.
Saundrea A Munroe1 insp.
Zhong Li1 insp.
Melanie M Walker1 insp.
Shafiq Ahadi1 insp.
Laurel A Beer1 insp.
Thomas R Withers1 insp.
Claire M Minden1 insp.
Hector A Carrero1 insp.
Erin C Hill1 insp.
Jared P Stevens1 insp.
Viviana Matta1 insp.
Yun Wu1 insp.
Gideon N Esuzor1 insp.
Carlos M Gonzalez1 insp.
Prabhu P Raju1 insp.
Monica C Burgos Garcia1 insp.
Adam R Cooke1 insp.
Michele L Forster1 insp.
Christian Lynch1 insp.
Larry K Hampton1 insp.
Rhonda Alexander1 insp.
Tammara A Stephens1 insp.
Joseph F Owens1 insp.
Cherrie A Zachary1 insp.
Donald C Obenhuber1 insp.
Michelle Y Clark Stuart1 insp.
Gabriel R Mclemore1 insp.
Tamika D Cathey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon Manufacturing Services LLC's 12 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat