Tanvex BioPharma USA, Inc
FDA inspection history in San Diego, California, 2019 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at San Diego, California.
- 2019The longest 483 on file: 20 observations over 10 pages at San Diego, California.
- 2022–23Two Form 483s, at San Diego, California.
Cited most
Across all Tanvex BioPharma USA observations on file
- 21 CFR 211.160General requirements6
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete Tanvex BioPharma USA 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
San Diego, California
Three Form 483s · 2019 to 2023 · 31 observations
Latest: Form 483, Jan 24, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-24 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2022-05-04 | 483 Form 483 | San Diego, California | 8 | $99 |
| 2019-05-02 | 483 Form 483 | San Diego, California | 20 | $99 |
Investigators on these documents
Aeicige Ia (1)Be Diane Raceasi (1)Bryan A. Galvez (1)Ian L. McWilliams (1)Jun Liu (1)Michael R. Shanks (1)Yi Wang (1)
FEI number 3013021112 · most recent document Jan 24, 2023
About Tanvex BioPharma USA, Inc
How many FDA Form 483s has Tanvex BioPharma USA, Inc received?
FDA Intel has 3 Form 483s on file for Tanvex BioPharma USA, Inc; the most recent is dated Jan 24, 2023.
When was Tanvex BioPharma USA, Inc last inspected by FDA?
The most recent FDA inspection document on file for Tanvex BioPharma USA, Inc is a Form 483 dated Jan 24, 2023, for the site in San Diego, California.
What did FDA cite at Tanvex BioPharma USA, Inc?
The regulations cited most in the observations on file for Tanvex BioPharma USA, Inc are 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.22 (Responsibilities of quality control unit), 5 times; 21 CFR 211.42 (Design and construction features), 5 times.