Patheon Manufacturing Services LLC
FDA inspection history in Ridgefield, New Jersey, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Ridgefield, New Jersey.
Cited most
Across all Patheon Manufacturing Services observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
The complete Patheon Manufacturing Services file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ridgefield, New Jersey
One Form 483 · 2024 · 3 observations
Latest: Form 483, Jun 13, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-13 | 483 Form 483 | Ridgefield, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 2246315 · most recent document Jun 13, 2024
About Patheon Manufacturing Services LLC
How many FDA Form 483s has Patheon Manufacturing Services LLC received?
FDA Intel has 1 Form 483 on file for Patheon Manufacturing Services LLC; the most recent is dated Jun 13, 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 Jun 13, 2024, for the site in Ridgefield, New Jersey.
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(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 1 time.