Synthetopes Inc.
FDA inspection history in Conway, South Carolina, 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 Conway, South Carolina.
Cited most
Across all Synthetopes observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167Special testing requirements1
- 21 CFR 211.192Production record review1
The complete Synthetopes file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Conway, South Carolina
One Form 483 · 2019 · 8 observations
Latest: Form 483, May 16, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-05-16 | 483 Form 483 | Conway, South Carolina | 8 | $99 |
Investigators on these documents
FEI number 3007488106 · most recent document May 16, 2019
About Synthetopes Inc.
How many FDA Form 483s has Synthetopes Inc. received?
FDA Intel has 1 Form 483 on file for Synthetopes Inc.; the most recent is dated May 16, 2019.
When was Synthetopes Inc. last inspected by FDA?
The most recent FDA inspection document on file for Synthetopes Inc. is a Form 483 dated May 16, 2019, for the site in Conway, South Carolina.
What did FDA cite at Synthetopes Inc.?
The regulations cited most in the observations on file for Synthetopes Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.