Dr. Reddy's Laboratories Ltd.
FDA inspection history across 4 sites, 2014 to 2024
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2017: one Form 483; 2020: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two Form 483s and one warning letter, at Pydibhimavaram, India; Andhra Pradesh, India and Srikakulam District, India.
- 2014The longest 483 on file: 9 observations over 9 pages at Pydibhimavaram, India.
- 2020One Form 483, at Srikakulam District, India.
- 2023–24Two Form 483s, at Hyderabad, India and Pydibhimavaram, India.
Cited most
Across all Dr. Reddy's Laboratories observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.180General requirements3
The complete Dr. Reddy's Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Pydibhimavaram, India
Two Form 483s · 2014 to 2024 · 13 observations
Latest: Form 483, Jun 7, 2024 →Srikakulam District, India
Two Form 483s · 2017 to 2020 · 6 observations
Latest: Form 483, Jan 28, 2020 →Hyderabad, India
One Form 483 · 2023 · 9 observations
Latest: Form 483, Oct 12, 2023 →Andhra Pradesh, India
One warning letter · 2015
Latest: Warning letter, Nov 5, 2015 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-07 | 483 Form 483 | Pydibhimavaram, India | 4 | $99 |
| 2023-10-12 | 483 Form 483 | Hyderabad, India | 9 | $99 |
| 2020-01-28 | 483 Form 483 | Srikakulam District, India | 4 | $99 |
| 2017-04-04 | 483 Form 483 | Srikakulam District, India | 2 | $99 |
| 2015-11-05 | Warning letter Warning letter | Andhra Pradesh, India | — | $99 |
| 2014-11-21 | 483 Form 483 | Pydibhimavaram, India | 9 | $99 |
Investigators on these documents
Dipesh K. Shah (2)Carmelo Rosa (1)Gayle S. Lawson (1)Joseph A. Piechocki (1)Kenneth H. Williams (1)Madushini Dharmasena (1)Peter E. Baker (1)Tamil Arasu (1)Aditi S. Thakur (1)Zhong Zhao (1)
FEI number 3002949085 · most recent document Jun 7, 2024
About Dr. Reddy's Laboratories Ltd.
How many FDA Form 483s has Dr. Reddy's Laboratories Ltd. received?
FDA Intel has 5 Form 483s on file for Dr. Reddy's Laboratories Ltd.; the most recent is dated Jun 7, 2024.
When was Dr. Reddy's Laboratories Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Dr. Reddy's Laboratories Ltd. is a Form 483 dated Jun 7, 2024, for the site in Pydibhimavaram, India.
What did FDA cite at Dr. Reddy's Laboratories Ltd.?
The regulations cited most in the observations on file for Dr. Reddy's Laboratories Ltd. are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.
Has Dr. Reddy's Laboratories Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Dr. Reddy's Laboratories Ltd.; the most recent is dated Nov 5, 2015.