Accu Bio-Chem Laboratories
FDA inspection history in Glendale, California, 2021 to 2022
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22One Form 483 and one warning letter, at Glendale, California.
Cited most
Across all Accu Bio-Chem Laboratories observations on file
- 21 CFR 211.194(a)(2)Laboratory records2
- 21 CFR 211.192Production record review1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete Accu Bio-Chem Laboratories 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
Glendale, California
One warning letter and one Form 483 · 2021 to 2022 · 4 observations
Latest: Warning letter, Feb 24, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-24 | Warning letter Warning letter | Glendale, California | — | $99 |
| 2021-08-31 | 483 Form 483 | Glendale, California | 4 | $99 |
Investigators on these documents
FEI number 3004876794 · most recent document Feb 24, 2022
About Accu Bio-Chem Laboratories
How many FDA Form 483s has Accu Bio-Chem Laboratories received?
FDA Intel has 1 Form 483 on file for Accu Bio-Chem Laboratories; the most recent is dated Aug 31, 2021.
When was Accu Bio-Chem Laboratories last inspected by FDA?
The most recent FDA inspection document on file for Accu Bio-Chem Laboratories is a Form 483 dated Aug 31, 2021, for the site in Glendale, California.
What did FDA cite at Accu Bio-Chem Laboratories?
The regulations cited most in the observations on file for Accu Bio-Chem Laboratories are 21 CFR 211.194(a)(2) (Laboratory records), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 1 time.
Has Accu Bio-Chem Laboratories received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Accu Bio-Chem Laboratories; the most recent is dated Feb 24, 2022.