Overview
- 19 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-19.
At a glance
Inspections
19
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 19 May 2026 | Biologics | 483 | View 483 → |
| 20 Aug 2024 – 30 Aug 2024 | Human Drugs | 483 | On file |
| 4 Jun 2024 – 13 Jun 2024 | Biologics | 483 | View 483 → |
| 11 Mar 2024 – 18 Mar 2024 | Human Drugs | 483 | View 483 → |
| 2 May 2022 – 6 May 2022 | Biologics | Clean | |
| 30 Oct 2018 – 17 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Nov 2017 – 7 Dec 2017 | Human Drugs | Clean | |
| 18 Aug 2015 – 26 Aug 2015 | Human Drugs | Clean | |
| 7 Jan 2014 – 21 Jan 2014 | Human Drugs | 483 | View 483 → |
| 12 Sep 2012 | Not recorded | Clean | |
| 21 Jun 2011 | Not recorded | 483 | View 483 → |
| 21 Dec 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2026
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Shafiq Ahadi, Laurel A Beer
19 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shafiq Ahadi, Laurel A Beer
13 Jun 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Unnee Ranjan, Peng Zhou, Richard L Bartlett
13 Jun 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Unnee Ranjan, Peng Zhou, Richard L Bartlett
Investigators
FDA investigators tied to this site in the record.
Michael R Klapal3 insp.
Alberto A Viciedo2 insp.
Karen E Dorazio2 insp.
Shafiq Ahadi1 insp.
Laurel A Beer1 insp.
Zhong Li1 insp.
Ekaterina Allen1 insp.
Unnee Ranjan1 insp.
Peng Zhou1 insp.
Richard L Bartlett1 insp.
Annet R Rajan1 insp.
Jessica S Estriplet1 insp.
Stephenie M Ortiz1 insp.
Paige R Mccoy1 insp.
Eileen A Liu1 insp.
Wei Wang1 insp.
Xiuju Lu1 insp.
Carl A Perez1 insp.
Frank J Marciniak1 insp.
Melissa A Zuppe1 insp.
Yvesna C Blaise1 insp.
Jose M Cayuela1 insp.
Zakaria I Ganiyu1 insp.
Jogy George1 insp.
Nikki S Ramirez1 insp.
Eric J Cunningham1 insp.
Douglas C Kovacs1 insp.
Sherry G Bous1 insp.
Thomas J Arista1 insp.
Melba T Rivera Clavell1 insp.
Robert G Ruff1 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 | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon Manufacturing Services LLC's 10 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