Dr. Reddy's Laboratories Limited (Unit II)
FDA inspection history across 2 sites, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Bollaram, India.
- 2024One Form 483, at Sangareddy, India.
- 2024The longest 483 on file: 5 observations over 10 pages at Sangareddy, India.
Cited most
Across all Dr. Reddy's Laboratories Limited (Unit II) observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.198Complaint files2
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Dr. Reddy's Laboratories Limited (Unit II) file.
All 2 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 · 5 observations
Latest: Form 483, Nov 19, 2024 →Bollaram, India
One Form 483 · 2019 · 1 observation
Latest: Form 483, Jul 12, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-19 | 483 Form 483 | Sangareddy, India | 5 | $99 |
| 2019-07-12 | 483 Form 483 | Bollaram, India | 1 | $99 |
Investigators on these documents
FEI number 3005448030 · most recent document Nov 19, 2024
About Dr. Reddy's Laboratories Limited (Unit II)
How many FDA Form 483s has Dr. Reddy's Laboratories Limited (Unit II) received?
FDA Intel has 2 Form 483s on file for Dr. Reddy's Laboratories Limited (Unit II); the most recent is dated Nov 19, 2024.
When was Dr. Reddy's Laboratories Limited (Unit II) last inspected by FDA?
The most recent FDA inspection document on file for Dr. Reddy's Laboratories Limited (Unit II) is a Form 483 dated Nov 19, 2024, for the site in Sangareddy, India.
What did FDA cite at Dr. Reddy's Laboratories Limited (Unit II)?
The regulations cited most in the observations on file for Dr. Reddy's Laboratories Limited (Unit II) are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.160 (General requirements), 1 time.