Patheon Manufacturing Services LLC
FDA inspection history in Greenville, North Carolina, 2014 to 2024
- 8
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2015: one Form 483; 2016: one Form 483; 2018: one Form 483; 2020: one Form 483; 2022: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–24Eight Form 483s, at Greenville, North Carolina.
- 2024The longest 483 on file: 4 observations over 10 pages at Greenville, North Carolina.
Cited most
Across all Patheon Manufacturing Services observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.130Packaging and labeling operations2
The complete Patheon Manufacturing Services file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Greenville, North Carolina
Eight Form 483s · 2014 to 2024 · 24 observations
Latest: Form 483, May 24, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-24 | 483 Form 483 | Greenville, North Carolina | 4 | $99 |
| 2024-02-23 | 483 Form 483 | Greenville, North Carolina | 1 | $99 |
| 2022-08-04 | 483 Form 483 | Greenville, North Carolina | 4 | $99 |
| 2020-08-14 | 483 Form 483 | Greenville, North Carolina | 2 | $99 |
| 2018-07-17 | 483 Form 483 | Greenville, North Carolina | 2 | $99 |
| 2016-11-18 | 483 Form 483 | Greenville, North Carolina | 4 | $99 |
| 2015-12-17 | 483 Form 483 | Greenville, North Carolina | 3 | $99 |
| 2014-09-12 | 483 Form 483 | Greenville, North Carolina | 4 | $99 |
Investigators on these documents
Christian Lynch (1)Claire M. Minden (1)Laurel A. Beer (1)Melanie M. Walker (1)Michele L. Forster (1)Prabhu P. Raju (1)Rhonda Alexander (1)Saundrea A. Munroe (1)Seneca Toms (1)Shafig Ahadi (1)Tammara A. Stephens (1)Thomas R. Withers (1)
FEI number 1018495 · most recent document May 24, 2024
About Patheon Manufacturing Services LLC
How many FDA Form 483s has Patheon Manufacturing Services LLC received?
FDA Intel has 8 Form 483s on file for Patheon Manufacturing Services LLC; the most recent is dated May 24, 2024.
When was Patheon Manufacturing Services LLC last inspected by FDA?
The most recent FDA inspection document on file for Patheon Manufacturing Services LLC is a Form 483 dated May 24, 2024, for the site in Greenville, North Carolina.
What did FDA cite at Patheon Manufacturing Services LLC?
The regulations cited most in the observations on file for Patheon Manufacturing Services LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 3 times.