Protein Sciences Corporation
FDA inspection history in Pearl River, New York, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Pearl River, New York.
- 2024One Form 483, at Pearl River, New York.
- 2024The longest 483 on file: 7 observations over 7 pages at Pearl River, New York.
Cited most
Across all Protein Sciences observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.160General requirements2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.198Complaint files1
The complete Protein Sciences file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pearl River, New York
Two Form 483s · 2019 to 2024 · 7 observations
Latest: Form 483, May 2, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-02 | 483 Form 483 | Pearl River, New York | 7 | $99 |
| 2019-05-31 | 483 Form 483 | Pearl River, New York | — | $99 |
Investigators on these documents
FEI number 3011286996 · most recent document May 2, 2024
About Protein Sciences Corporation
How many FDA Form 483s has Protein Sciences Corporation received?
FDA Intel has 2 Form 483s on file for Protein Sciences Corporation; the most recent is dated May 2, 2024.
When was Protein Sciences Corporation last inspected by FDA?
The most recent FDA inspection document on file for Protein Sciences Corporation is a Form 483 dated May 2, 2024, for the site in Pearl River, New York.
What did FDA cite at Protein Sciences Corporation?
The regulations cited most in the observations on file for Protein Sciences Corporation are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.