InvaGen Pharmaceuticals, Inc.
Form 483 issued December 6, 2019 · Hauppauge, New York
- Inspection
- Dec 2 – Dec 6, 2019
- Observations
- 3
- Pages
- 4
- FEI number
- 3003950641
In short: On December 6, 2019, FDA issued a Form 483 with 3 observations to InvaGen Pharmaceuticals, Inc. in Hauppauge, New York (FEI 3003950641) after an inspection that ran Dec 2 – Dec 6, 2019. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Written procedures are not followed that describe the in-process controls, tests and examinations to be conducted…
- 03
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Questions about this 483
What did FDA find at InvaGen Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
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.