Solara Active Pharma Sciences Limited
FDA inspection history in Cuddalore, India, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Cuddalore, India.
Cited most
Across all Solara Active Pharma Sciences Limited observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Solara Active Pharma Sciences Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Cuddalore, India
One Form 483 · 2020 · 6 observations
Latest: Form 483, Mar 7, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-07 | 483 Form 483 | Cuddalore, India | 6 | $99 |
Investigators on these documents
FEI number 3003585876 · most recent document Mar 7, 2020
About Solara Active Pharma Sciences Limited
How many FDA Form 483s has Solara Active Pharma Sciences Limited received?
FDA Intel has 1 Form 483 on file for Solara Active Pharma Sciences Limited; the most recent is dated Mar 7, 2020.
When was Solara Active Pharma Sciences Limited last inspected by FDA?
The most recent FDA inspection document on file for Solara Active Pharma Sciences Limited is a Form 483 dated Mar 7, 2020, for the site in Cuddalore, India.
What did FDA cite at Solara Active Pharma Sciences Limited?
The regulations cited most in the observations on file for Solara Active Pharma Sciences Limited are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.192 (Production record review), 1 time.