NATCO Pharma Limited Kothur Village, Mahaboob Nagar District
Form 483 issued January 24, 2017 · Mahaboob Nagar, India
- Inspection
- Jan 16 – Jan 24, 2017
- Investigators
- Anastasia M. Shields· Linda F. Murphy
- Observations
- 1
- Pages
- 6
- FEI number
- 3004540906
In short: On January 24, 2017, FDA issued a Form 483 with 1 observation to NATCO Pharma Limited Kothur Village, Mahaboob Nagar District in Mahaboob Nagar, India (FEI 3004540906) after an inspection that ran Jan 16 – Jan 24, 2017. The investigators were Anastasia M. Shields and Linda F. Murphy. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
Anastasia M. Shields and Linda F. Murphy are named on this Form 483, for the inspection of Jan 16 – Jan 24, 2017. 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 Jan 16 – Jan 24, 2017, and the Form 483 is dated January 24, 2017.
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.