Ipca Laboratories Limited 1/29/16
Form 483 issued July 18, 2014 · Ratlam, India
- Inspection
- Jul 14 – Jul 18, 2014
- Investigators
- Joanne E. King· Peter E. Baker
- Observations
- 6
- Pages
- 8
- FEI number
- 3002807297
In short: On July 18, 2014, 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 Jul 14 – Jul 18, 2014. The investigators were Joanne E. King and Peter E. Baker. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 11
Laboratory control records do not include complete data derived from all tests conducted to ensure compliance…
- 02
Laboratory control procedures are not followed and documented at…
- 03
Training is not conducted by qualified individuals covering GMP as it relates…
- 04
Your laboratory facilities for microbiological monitoring are not adequate to maintain stable incubation conditions for microbiological…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
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 211.160
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 facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Ipca Laboratories Limited 1/29/16?
Joanne E. King and Peter E. Baker are named on this Form 483, for the inspection of Jul 14 – Jul 18, 2014. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited 1/29/16 inspected by FDA?
The inspection ran Jul 14 – Jul 18, 2014, and the Form 483 is dated July 18, 2014.
How do I get the full Form 483 for Ipca Laboratories Limited 1/29/16?
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.