Impax Laboratories, Inc.
Form 483 issued March 28, 2012 · Hayward, California
- Inspection
- Feb 23 – Mar 28, 2012
- Investigators
- Peter E. Baker· V. Millar
- Observations
- 5
- Pages
- 8
- FEI number
- 3004182921
In short: On March 28, 2012, FDA issued a Form 483 with 5 observations to Impax Laboratories, Inc. in Hayward, California (FEI 3004182921) after an inspection that ran Feb 23 – Mar 28, 2012. The investigators were Peter E. Baker and V. Millar. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established standards and…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Written procedures for sampling and testing plans are not followed…
- 04
Written production and process control procedures are not followed in the execution of production…
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 firmImpax Laboratories, Inc. history
All 5 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 Impax Laboratories, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Impax Laboratories, Inc.?
Peter E. Baker and V. Millar are named on this Form 483, for the inspection of Feb 23 – Mar 28, 2012. Each investigator has a profile showing what they cite most.
When was Impax Laboratories, Inc. inspected by FDA?
The inspection ran Feb 23 – Mar 28, 2012, and the Form 483 is dated March 28, 2012.
How do I get the full Form 483 for Impax Laboratories, Inc.?
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.