Aktinos Pharma Private Limited
FDA inspection history in Visakhapatnam, India, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Visakhapatnam, India.
Cited most
Across all Aktinos Pharma Private Limited observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Aktinos Pharma Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Visakhapatnam, India
One Form 483 · 2018 · 6 observations
Latest: Form 483, Nov 1, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-01 | 483 Form 483 | Visakhapatnam, India | 6 | $99 |
Investigators on these documents
FEI number 3012575874 · most recent document Nov 1, 2018
About Aktinos Pharma Private Limited
How many FDA Form 483s has Aktinos Pharma Private Limited received?
FDA Intel has 1 Form 483 on file for Aktinos Pharma Private Limited; the most recent is dated Nov 1, 2018.
When was Aktinos Pharma Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Aktinos Pharma Private Limited is a Form 483 dated Nov 1, 2018, for the site in Visakhapatnam, India.
What did FDA cite at Aktinos Pharma Private Limited?
The regulations cited most in the observations on file for Aktinos Pharma Private Limited are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.25 (Personnel qualifications), 1 time.