Bioduro LLC
FDA inspection history in Irvine, California, 2017 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Irvine, California.
- 2024One Form 483, at Irvine, California.
- 2024The longest 483 on file: 8 observations over 7 pages at Irvine, California.
Cited most
Across all Bioduro observations on file
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.100(a)Written procedures; deviations1
The complete Bioduro file.
All 3 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
Irvine, California
Three Form 483s · 2017 to 2024 · 16 observations
Latest: Form 483, Feb 23, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-23 | 483 Form 483 | Irvine, California | 8 | $99 |
| 2019-09-06 | 483 Form 483 | Irvine, California | 4 | $99 |
| 2017-03-03 | 483 Form 483 | Irvine, California | 4 | $99 |
Investigators on these documents
FEI number 3004492248 · most recent document Feb 23, 2024
About Bioduro LLC
How many FDA Form 483s has Bioduro LLC received?
FDA Intel has 3 Form 483s on file for Bioduro LLC; the most recent is dated Feb 23, 2024.
When was Bioduro LLC last inspected by FDA?
The most recent FDA inspection document on file for Bioduro LLC is a Form 483 dated Feb 23, 2024, for the site in Irvine, California.
What did FDA cite at Bioduro LLC?
The regulations cited most in the observations on file for Bioduro LLC are 21 CFR 211.160(b) (General requirements), 3 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times.