Dr Reddy's Laboratories Limited
FDA inspection history across 2 sites, 2017 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Ranashthalam Mandal, Srikakulam, India.
- 2024–25Two Form 483s, at Srikakulam, India.
- 2025The longest 483 on file: 5 observations over 7 pages at Srikakulam, India.
Cited most
Across all Dr Reddy's Laboratories Limited observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Dr Reddy's Laboratories 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 · 2024 to 2025 · 8 observations
Latest: Form 483, Dec 12, 2025 →Ranashthalam Mandal, Srikakulam, India
Two Form 483s · 2017 to 2019 · 4 observations
Latest: Form 483, Jan 15, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-12 | 483 Form 483 | Srikakulam, India | 5 | $99 |
| 2024-08-23 | 483 Form 483 | Srikakulam, India | 3 | $99 |
| 2019-01-15 | 483 Form 483 | Ranashthalam Mandal, Srikakulam, India | 3 | $99 |
| 2017-06-16 | 483 Form 483 | Ranashthalam Mandal, Srikakulam, India | 1 | $99 |
Investigators on these documents
Justin A. Boyd (1)Lata Mathew (1)Rajiv R. Srivastava (1)Rumany C. Penn (1)Stacie Woods (1)
FEI number 3009193040 · most recent document Dec 12, 2025
About Dr Reddy's Laboratories Limited
How many FDA Form 483s has Dr Reddy's Laboratories Limited received?
FDA Intel has 4 Form 483s on file for Dr Reddy's Laboratories Limited; the most recent is dated Dec 12, 2025.
When was Dr Reddy's Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Dr Reddy's Laboratories Limited is a Form 483 dated Dec 12, 2025, for the site in Srikakulam, India.
What did FDA cite at Dr Reddy's Laboratories Limited?
The regulations cited most in the observations on file for Dr Reddy's Laboratories Limited are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times.