Regenesis Pharmaceutica l I nc
FDA inspection history in Santa Ana, California, 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 Santa Ana, California.
Cited most
Across all Regenesis Pharmaceutica l I nc observations on file
- 21 CFR 2111
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
The complete Regenesis Pharmaceutica l I nc file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Santa Ana, California
One Form 483 · 2019 · 12 observations
Latest: Form 483, Jun 18, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-18 | 483 Form 483 | Santa Ana, California | 12 | $99 |
Investigators on these documents
FEI number 3015180086 · most recent document Jun 18, 2019
About Regenesis Pharmaceutica l I nc
How many FDA Form 483s has Regenesis Pharmaceutica l I nc received?
FDA Intel has 1 Form 483 on file for Regenesis Pharmaceutica l I nc; the most recent is dated Jun 18, 2019.
When was Regenesis Pharmaceutica l I nc last inspected by FDA?
The most recent FDA inspection document on file for Regenesis Pharmaceutica l I nc is a Form 483 dated Jun 18, 2019, for the site in Santa Ana, California.
What did FDA cite at Regenesis Pharmaceutica l I nc?
The regulations cited most in the observations on file for Regenesis Pharmaceutica l I nc are 21 CFR 211, 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time.