Ipca Laboratories Limited
Form 483 issued December 19, 2014 · Piparia, India
- Inspection
- Dec 11 – Dec 19, 2014
- Investigators
- James Maclaughlin· Parul M. Patel
- Observations
- 5
- Pages
- 2
- FEI number
- 3005977675
In short: On December 19, 2014, FDA issued a Form 483 with 5 observations to Ipca Laboratories Limited in Piparia, U.T. of Dadra and Nagar Haveli and Daman and Diu (FEI 3005977675) after an inspection that ran Dec 11 – Dec 19, 2014. The investigators were James Maclaughlin and Parul M. Patel. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written procedure SOP/QCD/152/03 titled “Standard Chromatography Practice (HPLC and GC)” was not followed in that…
- 02
The documentation of laboratory tests and documentation result for” plate did not include scientifically, sound results…
- 03
The laboratory test did not include scientifically sound results for the growth promotion of microbiological culture…
- 04
filters installed on the system holding tanks (which includes feed tank tank, tank, ee tank are…
This inspection in context
James Maclaughlin
1 document · 2014
Cites 211.160 (general requirements) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ipca Laboratories Limited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Ipca Laboratories Limited?
James Maclaughlin and Parul M. Patel are named on this Form 483, for the inspection of Dec 11 – Dec 19, 2014. Each investigator has a profile showing what they cite most.
When was Ipca Laboratories Limited inspected by FDA?
The inspection ran Dec 11 – Dec 19, 2014, and the Form 483 is dated December 19, 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.