NATCO Pharma Limited Kothur Village, Mahaboob Nagar District
Form 483 issued June 19, 2025 · Rangareddy, India
- Inspection
- Jun 9 – Jun 19, 2025
- Investigators
- Arsen Karapetyan· Wayne D. McGrath
- Observations
- 7
- Pages
- 9
- FEI number
- 3004540906
In short: On June 19, 2025, FDA issued a Form 483 with 7 observations to NATCO Pharma Limited Kothur Village, Mahaboob Nagar District in Rangareddy, Telangana (FEI 3004540906) after an inspection that ran Jun 9 – Jun 19, 2025. The investigators were Arsen Karapetyan and Wayne D. McGrath. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmNATCO Pharma Limited Kothur Village, Mahaboob Nagar District history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
Arsen Karapetyan and Wayne D. McGrath are named on this Form 483, for the inspection of Jun 9 – Jun 19, 2025. Each investigator has a profile showing what they cite most.
When was NATCO Pharma Limited Kothur Village, Mahaboob Nagar District inspected by FDA?
The inspection ran Jun 9 – Jun 19, 2025, and the Form 483 is dated June 19, 2025.
How do I get the full Form 483 for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.