InvaGen Pharmaceuticals, Inc.
Form 483 issued May 25, 2018 · Hauppauge, New York
- Inspection
- May 9 – May 25, 2018
- Investigator
- Bijoy Panicker
- Observations
- 6
- Pages
- 6
- FEI number
- 3003950641
In short: On May 25, 2018, FDA issued a Form 483 with 6 observations to InvaGen Pharmaceuticals, Inc. in Hauppauge, New York (FEI 3003950641) after an inspection that ran May 9 – May 25, 2018. The investigator was Bijoy Panicker. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 3 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The written stability testing…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) 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 314.81(b)(1)(ii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InvaGen Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected InvaGen Pharmaceuticals, Inc.?
Bijoy Panicker is named on this Form 483, for the inspection of May 9 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 9 – May 25, 2018, and the Form 483 is dated May 25, 2018.
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.