Biocore9
FDA inspection history in Whippany, New Jersey, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One amended 483, at Whippany, New Jersey.
Cited most
Across all Biocore9 observations on file
- 21 CFR 820.30Design controls6
- 21 CFR 803.17(a)(3)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.50Purchasing controls1
The complete Biocore9 file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Whippany, New Jersey
One amended 483 · 2023 · 12 observations
Latest: Form 483, Nov 6, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-06 | Amended 483 Amended 483 | Whippany, New Jersey | 12 | $99 |
Investigators on these documents
Monica L. Gutierrez (1)Naakesh N. Gomanie (1)William R. Chang (1)
FEI number 3020162561 · most recent document Nov 6, 2023
About Biocore9
How many FDA Form 483s has Biocore9 received?
FDA Intel has 1 Form 483 on file for Biocore9; the most recent is dated Nov 6, 2023.
When was Biocore9 last inspected by FDA?
The most recent FDA inspection document on file for Biocore9 is a Form 483 dated Nov 6, 2023, for the site in Whippany, New Jersey.
What did FDA cite at Biocore9?
The regulations cited most in the observations on file for Biocore9 are 21 CFR 820.30 (Design controls), 6 times; 21 CFR 803.17(a)(3) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.