InvaGen Pharmaceuticals, Inc.
Form 483 issued September 19, 2023 · Central Islip, New York
- Inspection
- Sep 11 – Sep 19, 2023
- Investigator
- Amatul H. Marium
- Observations
- 5
- Pages
- 5
- FEI number
- 3012696190
In short: On September 19, 2023, FDA issued a Form 483 with 5 observations to InvaGen Pharmaceuticals, Inc. in Central Islip, New York (FEI 3012696190) after an inspection that ran Sep 11 – Sep 19, 2023. The investigator was Amatul H. Marium. Most observations concern production and packaging & labeling.
At a glance
Production and packaging & labeling account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not reviewed and approved by…
- 02
In-process materials are not tested for and approved or rejected by the quality control unit during…
- 03
Labeling and packaging materials are not representatively sampled, examined and tested upon receipt and before use…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmInvaGen Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
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 production, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected InvaGen Pharmaceuticals, Inc.?
Amatul H. Marium is named on this Form 483, for the inspection of Sep 11 – Sep 19, 2023. Each investigator has a profile showing what they cite most.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Sep 11 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
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.