Ipca Laboratories Limited
Form 483 issued October 17, 2014 · Indore, India
- Inspection
- Oct 13 – Oct 17, 2014
- Investigator
- Peter E. Baker
- Observations
- 6
- Pages
- 6
- FEI number
- 3007574780
In short: On October 17, 2014, FDA issued a Form 483 with 6 observations to Ipca Laboratories Limited in Indore, Madhya Pradesh (FEI 3007574780) after an inspection that ran Oct 13 – Oct 17, 2014. The investigator was Peter E. Baker. 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×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
Established laboratory control mechanisms are not followed. Electronic records are used, but they do not meet…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Peter E. Baker
11 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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?
Peter E. Baker is named on this Form 483, for the inspection of Oct 13 – Oct 17, 2014. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited inspected by FDA?
The inspection ran Oct 13 – Oct 17, 2014, and the Form 483 is dated October 17, 2014.
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.