Ipca Laboratories Limited
Form 483 issued April 26, 2023 · Piparia, Silvassa, India
- Inspection
- Apr 18 – Apr 26, 2023
- Investigators
- Kellia N. Hicks· Rajiv R. Srivastava
- Observations
- 2
- Pages
- 7
- FEI number
- 3005977675
In short: On April 26, 2023, FDA issued a Form 483 with 2 observations to Ipca Laboratories Limited in Piparia, Silvassa, India (FEI 3005977675) after an inspection that ran Apr 18 – Apr 26, 2023. The investigators were Kellia N. Hicks and Rajiv R. Srivastava. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ipca Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Ipca Laboratories Limited?
Kellia N. Hicks and Rajiv R. Srivastava are named on this Form 483, for the inspection of Apr 18 – Apr 26, 2023. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited inspected by FDA?
The inspection ran Apr 18 – Apr 26, 2023, and the Form 483 is dated April 26, 2023.
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.