Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post
FDA inspection history across 3 sites, 2016 to 2024
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one Form 483; 2017: one close-out letter and one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483, one close-out letter and one warning letter, at Visakhapatnam District, India and Andhra Pradesh, India.
- 2016The longest 483 on file: 5 observations over 18 pages at Visakhapatnam District, India.
- 2024One Form 483, at Visakhapatnam, India.
Cited most
Across all Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.180General requirements1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post 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
Visakhapatnam, India
One Form 483 · 2024 · 1 observation
Latest: Form 483, Jul 19, 2024 →Andhra Pradesh, India
One warning letter · 2017
Latest: Warning letter, Apr 13, 2017 →Visakhapatnam District, India
One Form 483 · 2016 · 5 observations
Latest: Form 483, Dec 6, 2016 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-19 | 483 Form 483 | Visakhapatnam, India | 1 | $99 |
| 2017-11-07 | Close-out Close-out letter | — | — | $99 |
| 2017-04-13 | Warning letter Warning letter | Andhra Pradesh, India | — | $99 |
| 2016-12-06 | 483 Form 483 | Visakhapatnam District, India | 5 | $99 |
Investigators on these documents
FEI number 3004149463 · most recent document Jul 19, 2024
About Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post
How many FDA Form 483s has Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post received?
FDA Intel has 2 Form 483s on file for Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post; the most recent is dated Jul 19, 2024.
When was Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post last inspected by FDA?
The most recent FDA inspection document on file for Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post is a Form 483 dated Jul 19, 2024, for the site in Visakhapatnam, India.
What did FDA cite at Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post?
The regulations cited most in the observations on file for Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.180 (General requirements), 1 time.
Has Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post; the most recent is dated Apr 13, 2017.