Natco Pharma Limited
Form 483 issued August 9, 2019 · Rangareddy, India
- Inspection
- Aug 5 – Aug 9, 2019
- Investigator
- Yvins Dezan
- Observations
- 6
- Pages
- 5
- FEI number
- 3004065860
In short: On August 9, 2019, FDA issued a Form 483 with 6 observations to Natco Pharma Limited in Rangareddy, Telangana (FEI 3004065860) after an inspection that ran Aug 5 – Aug 9, 2019. The investigator was Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Employees engaged in the manufacture and packing of finished API materials lack the training and experience…
- 03
Process Validation (PV) has not been performed to substantiate evidence that the process, operated within established…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natco Pharma Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Natco Pharma Limited?
Yvins Dezan is named on this Form 483, for the inspection of Aug 5 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Natco Pharma Limited inspected by FDA?
The inspection ran Aug 5 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
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.