Ipca Laboratories Limited
Form 483 issued August 23, 2019 · Silvasa, India
- Inspection
- Aug 19 – Aug 23, 2019
- Investigators
- Arsen Karapetyan· Pratik S. Upadhyay
- Observations
- 3
- Pages
- 10
- FEI number
- 3005977675
In short: On August 23, 2019, FDA issued a Form 483 with 3 observations to Ipca Laboratories Limited in Silvasa, India (FEI 3005977675) after an inspection that ran Aug 19 – Aug 23, 2019. The investigators were Arsen Karapetyan and Pratik S. Upadhyay. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written test procedures and laboratory mechanisms are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
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 firmIpca Laboratories Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ipca Laboratories Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ipca Laboratories Limited?
Arsen Karapetyan and Pratik S. Upadhyay are named on this Form 483, for the inspection of Aug 19 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited inspected by FDA?
The inspection ran Aug 19 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Ipca Laboratories 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.