Opti Source International
FDA inspection history in Bellport, New York, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Bellport, New York.
Cited most
Across all Opti Source International observations on file
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.180(e)(1)General requirements1
The complete Opti Source International file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bellport, New York
One Form 483 · 2024 · 11 observations
Latest: Form 483, Apr 4, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-04 | 483 Form 483 | Bellport, New York | 11 | $99 |
Investigators on these documents
FEI number 3004507660 · most recent document Apr 4, 2024
About Opti Source International
How many FDA Form 483s has Opti Source International received?
FDA Intel has 1 Form 483 on file for Opti Source International; the most recent is dated Apr 4, 2024.
When was Opti Source International last inspected by FDA?
The most recent FDA inspection document on file for Opti Source International is a Form 483 dated Apr 4, 2024, for the site in Bellport, New York.
What did FDA cite at Opti Source International?
The regulations cited most in the observations on file for Opti Source International are 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.