Impax Laboratories, Inc.
Form 483 issued February 28, 2013 · Hayward, California
- Inspection
- Jan 8 – Feb 28, 2013
- Investigators
- Daniel J. Roberts· Kim L. Thomas Cruse· Walden H. Lee
- Observations
- 12
- Pages
- 12
- FEI number
- 3004182921
In short: On February 28, 2013, FDA issued a Form 483 with 12 observations to Impax Laboratories, Inc. in Hayward, California (FEI 3004182921) after an inspection that ran Jan 8 – Feb 28, 2013. The investigators were Daniel J. Roberts, Kim L. Thomas Cruse and Walden H. Lee. Most observations concern materials and production.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity, and reproducibility of test methods have…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Impax Laboratories, Inc.?
FDA listed 12 observations on this Form 483, mostly about materials, production and quality system. The opening words of each observation are shown on this page.
Who inspected Impax Laboratories, Inc.?
Daniel J. Roberts, Kim L. Thomas Cruse and Walden H. Lee are named on this Form 483, for the inspection of Jan 8 – Feb 28, 2013. Each investigator has a profile showing what they cite most.
When was Impax Laboratories, Inc. inspected by FDA?
The inspection ran Jan 8 – Feb 28, 2013, and the Form 483 is dated February 28, 2013.
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.