Durisan
FDA inspection history in Sarasota, Florida, 2019 to 2021
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21One Form 483 and one warning letter, at Sarasota, Florida.
Cited most
Across all Durisan observations on file
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.188(b)Batch production and control records1
The complete Durisan 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
Sarasota, Florida
One warning letter and one Form 483 · 2019 to 2021 · 9 observations
Latest: Warning letter, Jul 27, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-27 | Warning letter Warning letter | Sarasota, Florida | — | $99 |
| 2019-05-17 | 483 Form 483 | Sarasota, Florida | 9 | $99 |
Investigators on these documents
FEI number 3014538924 · most recent document Jul 27, 2021
About Durisan
How many FDA Form 483s has Durisan received?
FDA Intel has 1 Form 483 on file for Durisan; the most recent is dated May 17, 2019.
When was Durisan last inspected by FDA?
The most recent FDA inspection document on file for Durisan is a Form 483 dated May 17, 2019, for the site in Sarasota, Florida.
What did FDA cite at Durisan?
The regulations cited most in the observations on file for Durisan are 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.
Has Durisan received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Durisan; the most recent is dated Jul 27, 2021.