Ipca Laboratories Limited
Form 483 issued June 23, 2023 · Dhar, India
- Inspection
- Jun 15 – Jun 23, 2023
- Investigators
- Rajiv R. Srivastava· Saleem A. Akhtar· Wenzheng Zhang
- Observations
- 8
- Pages
- 18
- FEI number
- 3007574780
In short: On June 23, 2023, FDA issued a Form 483 with 8 observations to Ipca Laboratories Limited in Dhar, Madhya Pradesh (FEI 3007574780) after an inspection that ran Jun 15 – Jun 23, 2023. The investigators were Rajiv R. Srivastava, Saleem A. Akhtar and Wenzheng Zhang. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 8 observations.
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
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
The suitability of all testing methods is not verified under…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
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 2 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 8 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ipca Laboratories Limited?
Rajiv R. Srivastava, Saleem A. Akhtar and Wenzheng Zhang are named on this Form 483, for the inspection of Jun 15 – Jun 23, 2023. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited inspected by FDA?
The inspection ran Jun 15 – Jun 23, 2023, and the Form 483 is dated June 23, 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.