Impax Laboratories, Inc.
Form 483 issued May 4, 2016 · Hayward, California
- Inspection
- Apr 4 – May 4, 2016
- Investigators
- Elizabeth Juarez· Lucila B. Nwatu· Stephanie A. Slater
- Observations
- 4
- Pages
- 7
- FEI number
- 3004182921
In short: On May 4, 2016, FDA issued a Form 483 with 4 observations to Impax Laboratories, Inc. in Hayward, California (FEI 3004182921) after an inspection that ran Apr 4 – May 4, 2016. The investigators were Elizabeth Juarez, Lucila B. Nwatu and Stephanie A. Slater. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 314.80 (3×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned , maintained and sanitized at appropriate intervals to prevent contamination…
- 02
Written procedures have not been developed for the surveillance , receipt , evaluation and reporting to…
- 03
You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports…
- 04
Adverse drug experience information obtained or otherwise received from any source was not reviewed, including information…
This inspection in context
Elizabeth Juarez
1 document · 2016
Cites 314.80 (postmarketing reporting of adverse drug experiences) 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 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Impax Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Impax Laboratories, Inc.?
Elizabeth Juarez, Lucila B. Nwatu and Stephanie A. Slater are named on this Form 483, for the inspection of Apr 4 – May 4, 2016. Each investigator has a profile showing what they cite most.
When was Impax Laboratories, Inc. inspected by FDA?
The inspection ran Apr 4 – May 4, 2016, and the Form 483 is dated May 4, 2016.
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.