Apitoria Pharma Private Limited
FDA inspection history across 3 sites, 2019 to 2023
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483; 2022: one Form 483; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at Hyderabad, India and Srikakulam, India.
- 2019The longest 483 on file: 3 observations over 4 pages at Srikakulam, India.
- 2022–23One Form 483 and one close-out letter, at Srikakulam, India and Srikakulam District, India.
Cited most
Across all Apitoria Pharma Private Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
The complete Apitoria Pharma Private Limited file.
All 4 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
Srikakulam, India
Two Form 483s · 2019 to 2022 · 6 observations
Latest: Form 483, Aug 2, 2022 →Srikakulam District, India
One close-out letter · 2023
Latest: Close-out, Feb 9, 2023 →Hyderabad, India
One close-out letter · 2019
Latest: Close-out, Jun 20, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-09 | Close-out Close-out letter | Srikakulam District, India | — | $99 |
| 2022-08-02 | 483 Form 483 | Srikakulam, India | 3 | $99 |
| 2019-06-20 | Close-out Close-out letter | Hyderabad, India | — | $99 |
| 2019-02-09 | 483 Form 483 | Srikakulam, India | 3 | $99 |
Investigators on these documents
FEI number 3004611182 · most recent document Feb 9, 2023
About Apitoria Pharma Private Limited
How many FDA Form 483s has Apitoria Pharma Private Limited received?
FDA Intel has 2 Form 483s on file for Apitoria Pharma Private Limited; the most recent is dated Aug 2, 2022.
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 Aug 2, 2022, for the site in Srikakulam, 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 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.