Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
FDA inspection history across 3 sites, 2017 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20Three Form 483s, at Bachupally, India and Medchal-Malkajgiri, India.
- 2023One Form 483, at Medchal - Malkajgiri, India.
- 2023The longest 483 on file: 10 observations over 23 pages at Medchal - Malkajgiri, India.
Cited most
Across all Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal observations on file
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.198(a)Complaint files2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(e)Testing and release for distribution1
The complete Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal 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
Bachupally, India
Two Form 483s · 2017 to 2019 · 3 observations
Latest: Form 483, Feb 8, 2019 →Medchal - Malkajgiri, India
One Form 483 · 2023 · 10 observations
Latest: Form 483, Oct 27, 2023 →Medchal-Malkajgiri, India
One Form 483 · 2020 · 1 observation
Latest: Form 483, Feb 28, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-27 | 483 Form 483 | Medchal - Malkajgiri, India | 10 | $99 |
| 2020-02-28 | 483 Form 483 | Medchal-Malkajgiri, India | 1 | $99 |
| 2019-02-08 | 483 Form 483 | Bachupally, India | 1 | $99 |
| 2017-04-28 | 483 Form 483 | Bachupally, India | 2 | $99 |
Investigators on these documents
Angela E. Glenn (2)Cheryl Clausen (2)Frederick Razzaghi (1)Pratik S. Upadhyay (1)Saleem A. Akhtar (1)
FEI number 3002949099 · most recent document Oct 27, 2023
About Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
How many FDA Form 483s has Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal received?
FDA Intel has 4 Form 483s on file for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal; the most recent is dated Oct 27, 2023.
When was Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal last inspected by FDA?
The most recent FDA inspection document on file for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal is a Form 483 dated Oct 27, 2023, for the site in Medchal - Malkajgiri, India.
What did FDA cite at Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
The regulations cited most in the observations on file for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal are 21 CFR 211.160(b) (General requirements), 3 times; 21 CFR 211.198(a) (Complaint files), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.