Natco Pharma Limited
Form 483 issued February 3, 2023 · Anakapalli, India
- Inspection
- Jan 24 – Feb 3, 2023
- Investigators
- Dennis Cantellops· Wayne D. McGrath
- Observations
- 2
- Pages
- 1
- FEI number
- 3015380536
In short: On February 3, 2023, FDA issued a Form 483 with 2 observations to Natco Pharma Limited in Anakapalli, Andhra Pradesh (FEI 3015380536) after an inspection that ran Jan 24 – Feb 3, 2023. The investigators were Dennis Cantellops and Wayne D. McGrath. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not documented at…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
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 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natco Pharma Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Natco Pharma Limited?
Dennis Cantellops and Wayne D. McGrath are named on this Form 483, for the inspection of Jan 24 – Feb 3, 2023. Each investigator has a profile showing what they cite most.
When was Natco Pharma Limited inspected by FDA?
The inspection ran Jan 24 – Feb 3, 2023, and the Form 483 is dated February 3, 2023.
How do I get the full Form 483 for Natco Pharma Limited?
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.