InvaGen Pharmaceuticals, Inc.
Form 483 issued March 13, 2015 · Hauppauge, New York
- Inspection
- Feb 23 – Mar 13, 2015
- Investigators
- Alice S. Tsao· Mindy M. Chou
- Observations
- 5
- Pages
- 3
- FEI number
- 3003950641
In short: On March 13, 2015, FDA issued a Form 483 with 5 observations to InvaGen Pharmaceuticals, Inc. in Hauppauge, New York (FEI 3003950641) after an inspection that ran Feb 23 – Mar 13, 2015. The investigators were Alice S. Tsao and Mindy M. Chou. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 314.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures describing the warehousing of drug…
- 03
Written procedures for cleaning and maintenance fail to include parameters…
- 04
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmInvaGen Pharmaceuticals, 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 InvaGen Pharmaceuticals, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and 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 InvaGen Pharmaceuticals, Inc.?
Alice S. Tsao and Mindy M. Chou are named on this Form 483, for the inspection of Feb 23 – Mar 13, 2015. Each investigator has a profile showing what they cite most.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 23 – Mar 13, 2015, and the Form 483 is dated March 13, 2015.
How do I get the full Form 483 for InvaGen Pharmaceuticals, 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.