NATCO Pharma Limited Kothur Village, Mahaboob Nagar District
FDA inspection history across 4 sites, 2017 to 2025
- 5
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2017: one Form 483; 2019: one Form 483; 2023: two Form 483s; 2024: one warning letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Mahaboob Nagar, India and Kothur, India.
- 2019The longest 483 on file: 9 observations over 11 pages at Kothur, India.
- 2023–25Three Form 483s and one warning letter, at Kothur, India; Rangareddy, India and Hyderabad, India.
Cited most
Across all NATCO Pharma Limited Kothur Village, Mahaboob Nagar District observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete NATCO Pharma Limited Kothur Village, Mahaboob Nagar District file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Rangareddy, India
Two Form 483s and one close-out letter · 2023 to 2025 · 15 observations
Latest: Form 483, Jun 19, 2025 →Kothur, India
Two Form 483s · 2019 to 2023 · 14 observations
Latest: Form 483, Oct 18, 2023 →Hyderabad, India
One warning letter · 2024
Latest: Warning letter, Apr 8, 2024 →Mahaboob Nagar, India
One Form 483 · 2017 · 1 observation
Latest: Form 483, Jan 24, 2017 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-19 | 483 Form 483 | Rangareddy, India | 7 | $99 |
| 2024-04-08 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2023-10-18 | 483 Form 483 | Kothur, India | 5 | $99 |
| 2023-10-18 | 483 Form 483 | Rangareddy, India | 8 | $99 |
| 2019-06-06 | 483 Form 483 | Kothur, India | 9 | $99 |
| 2017-01-24 | 483 Form 483 | Mahaboob Nagar, India | 1 | $99 |
| Undated | Close-out Close-out letter | Rangareddy, India | — | $99 |
Investigators on these documents
Saleem A. Akhtar (2)Pratik S. Upadhyay (2)Linda F. Murphy (1)Anastasia M. Shields (1)Wayne D. McGrath (1)Patric C. Klotzbuecher (1)Arsen Karapetyan (1)
FEI number 3004540906 · most recent document Jun 19, 2025
About NATCO Pharma Limited Kothur Village, Mahaboob Nagar District
How many FDA Form 483s has NATCO Pharma Limited Kothur Village, Mahaboob Nagar District received?
FDA Intel has 5 Form 483s on file for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District; the most recent is dated Jun 19, 2025.
When was NATCO Pharma Limited Kothur Village, Mahaboob Nagar District last inspected by FDA?
The most recent FDA inspection document on file for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District is a Form 483 dated Jun 19, 2025, for the site in Rangareddy, India.
What did FDA cite at NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
The regulations cited most in the observations on file for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 5 times; 21 CFR 211.192 (Production record review), 4 times.
Has NATCO Pharma Limited Kothur Village, Mahaboob Nagar District received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District; the most recent is dated Apr 8, 2024.