FEI 3013133723
FDA inspection history in Sarasota, Florida, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Sarasota, Florida.
Cited most
Across all site observations on file
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 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 site file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sarasota, Florida
One Form 483 · 2019 · 8 observations
Latest: Form 483, Nov 4, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-04 | 483 Form 483 | Sarasota, Florida | 8 | $99 |
Investigators on these documents
FEI number 3013133723 · most recent document Nov 4, 2019
About FEI 3013133723
How many FDA Form 483s has FEI 3013133723 received?
FDA Intel has 1 Form 483 on file for FEI 3013133723; the most recent is dated Nov 4, 2019.
When was FEI 3013133723 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3013133723 is a Form 483 dated Nov 4, 2019, for the site in Sarasota, Florida.
What did FDA cite at FEI 3013133723?
The regulations cited most in the observations on file for FEI 3013133723 are 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.