Impax Laboratories, Inc.
Form 483 issued May 8, 2015 · Hayward, California
- Inspection
- Apr 6 – May 8, 2015
- Investigators
- Anh Lac· Ashar P. Parikh· Lucila B. Nwatu
- Observations
- 3
- Pages
- 6
- FEI number
- 3004182921
In short: On May 8, 2015, FDA issued a Form 483 with 3 observations to Impax Laboratories, Inc. in Hayward, California (FEI 3004182921) after an inspection that ran Apr 6 – May 8, 2015. The investigators were Anh Lac, Ashar P. Parikh, Lucila B. Nwatu, Rebecca Rodriguez, Stephanie A. Slater and Uduak M. Inokon. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review' any unexplained discrepancy and the failure of a batch…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Impax Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Impax Laboratories, Inc.?
Anh Lac, Ashar P. Parikh, Lucila B. Nwatu, Rebecca Rodriguez, Stephanie A. Slater and Uduak M. Inokon are named on this Form 483, for the inspection of Apr 6 – May 8, 2015. Each investigator has a profile showing what they cite most.
When was Impax Laboratories, Inc. inspected by FDA?
The inspection ran Apr 6 – May 8, 2015, and the Form 483 is dated May 8, 2015.
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.