Ipca Laboratories Limited 1/29/16
Form 483 issued June 13, 2023 · Ratlam, India
- Inspection
- Jun 5 – Jun 13, 2023
- Investigators
- Rajiv R. Srivastava· Saleem A. Akhtar· Wenzheng Zhang
- Observations
- 6
- Pages
- 18
- FEI number
- 3002807297
In short: On June 13, 2023, FDA issued a Form 483 with 6 observations to Ipca Laboratories Limited 1/29/16 in Ratlam, Madhya Pradesh (FEI 3002807297) after an inspection that ran Jun 5 – Jun 13, 2023. The investigators were Rajiv R. Srivastava, Saleem A. Akhtar and Wenzheng Zhang. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate to determine the toot cause for the failure of a batch of intermediate…
- 02
The Quality Unit failed to take adequate actions against the failing API batches being sold in…
- 03
The reworked API is not subjected to appropriate evaluation, testing, stability testing if warranted, and documentation…
- 04
You fail to establish optimal processing condition that. ensures consistency. in critical quality attributes…
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 1/29/16 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 1/29/16?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. 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 1/29/16?
Rajiv R. Srivastava, Saleem A. Akhtar and Wenzheng Zhang are named on this Form 483, for the inspection of Jun 5 – Jun 13, 2023. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited 1/29/16 inspected by FDA?
The inspection ran Jun 5 – Jun 13, 2023, and the Form 483 is dated June 13, 2023.
How do I get the full Form 483 for Ipca Laboratories Limited 1/29/16?
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