Genlabs Corporation
FDA inspection history in Chino, California, 2015 to 2022
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Chino, California.
- 2022One warning letter, at Chino, California.
Cited most
Across all Genlabs observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.180(e)(2)General requirements1
The complete Genlabs 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
Chino, California
One warning letter and one Form 483 · 2015 to 2022 · 10 observations
Latest: Warning letter, May 12, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-12 | Warning letter Warning letter | Chino, California | — | $99 |
| 2015-12-11 | 483 Form 483 | Chino, California | 10 | $99 |
Investigators on these documents
FEI number 1000125638 · most recent document May 12, 2022
About Genlabs Corporation
How many FDA Form 483s has Genlabs Corporation received?
FDA Intel has 1 Form 483 on file for Genlabs Corporation; the most recent is dated Dec 11, 2015.
When was Genlabs Corporation last inspected by FDA?
The most recent FDA inspection document on file for Genlabs Corporation is a Form 483 dated Dec 11, 2015, for the site in Chino, California.
What did FDA cite at Genlabs Corporation?
The regulations cited most in the observations on file for Genlabs Corporation are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b)(4) (General requirements), 1 time.
Has Genlabs Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Genlabs Corporation; the most recent is dated May 12, 2022.