Apitoria Pharma Private Limited
FDA inspection history across 2 sites, 2016 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483.
- 2019One Form 483, at Jinnaram Mandal, India.
- 2024One Form 483, at Sangareddy, India.
- 2024The longest 483 on file: 10 observations over 8 pages at Sangareddy, India.
Cited most
Across all Apitoria Pharma Private Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.166Stability testing1
The complete Apitoria Pharma Private Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sangareddy, India
One Form 483 · 2024 · 10 observations
Latest: Form 483, Sep 27, 2024 →Jinnaram Mandal, India
One Form 483 · 2019 · 3 observations
Latest: Form 483, Oct 25, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-27 | 483 Form 483 | Sangareddy, India | 10 | $99 |
| 2019-10-25 | 483 Form 483 | Jinnaram Mandal, India | 3 | $99 |
| 2016-07-01 | 483 Form 483 | — | 1 | $99 |
Investigators on these documents
Gayle S. Lawson (1)Kenneth H. Williams (1)Khalid M. Khan (1)Pushpa Suresh (1)
FEI number 3004086884 · most recent document Sep 27, 2024
About Apitoria Pharma Private Limited
How many FDA Form 483s has Apitoria Pharma Private Limited received?
FDA Intel has 3 Form 483s on file for Apitoria Pharma Private Limited; the most recent is dated Sep 27, 2024.
When was Apitoria Pharma Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Apitoria Pharma Private Limited is a Form 483 dated Sep 27, 2024, for the site in Sangareddy, India.
What did FDA cite at Apitoria Pharma Private Limited?
The regulations cited most in the observations on file for Apitoria Pharma Private Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.160 (General requirements), 2 times.