InvaGen Pharmaceuticals, Inc.
Form 483 issued December 19, 2018 · Central Islip, New York
- Inspection
- Dec 10 – Dec 19, 2018
- Investigator
- Jose O. Hernandez
- Observations
- 3
- Pages
- 3
- FEI number
- 3012696190
In short: On December 19, 2018, FDA issued a Form 483 with 3 observations to InvaGen Pharmaceuticals, Inc. in Central Islip, New York (FEI 3012696190) after an inspection that ran Dec 10 – Dec 19, 2018. The investigator was Jose O. Hernandez. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.82 (receipt and storage of untested components, drug product containers, and closures).
At a glance
Materials and production account for 2 of 2 observations.
Most cited: 21 CFR 211.82 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Incoming components are not stored under quarantine until they have been tested or examined…
- 02
Your in-process specifications for sampling and testing of in-process materials and drug products were not determined…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) 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 211.82
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InvaGen Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.82 (receipt and storage of untested components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected InvaGen Pharmaceuticals, Inc.?
Jose O. Hernandez is named on this Form 483, for the inspection of Dec 10 – Dec 19, 2018. Each investigator has a profile showing what they cite most.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Dec 10 – Dec 19, 2018, and the Form 483 is dated December 19, 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.