InvaGen Pharmaceuticals, Inc.
Form 483 issued May 26, 2015 · Hauppauge, New York
- Inspection
- May 13 – May 26, 2015
- Investigator
- Robert C. Horan
- Observations
- 1
- Pages
- 2
- FEI number
- 3003950641
In short: On May 26, 2015, FDA issued a Form 483 with 1 observation to InvaGen Pharmaceuticals, Inc. in Hauppauge, New York (FEI 3003950641) after an inspection that ran May 13 – May 26, 2015. The investigator was Robert C. Horan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InvaGen Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected InvaGen Pharmaceuticals, Inc.?
Robert C. Horan is named on this Form 483, for the inspection of May 13 – May 26, 2015. Each investigator has a profile showing what they cite most.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 13 – May 26, 2015, and the Form 483 is dated May 26, 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.