InvaGen Pharmaceuticals, Inc.
Form 483 issued March 30, 2017 · Hauppauge, New York
- Observations
- 3
- Pages
- 2
- FEI number
- 3003950641
In short: On March 30, 2017, FDA issued a Form 483 with 3 observations to InvaGen Pharmaceuticals, Inc. in Hauppauge, New York (FEI 3003950641). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain a backup file of data entered into the…
- 0221 CFR 11
Appropriate controls are not exercised over computer or related systems to assure that changes in master…
- 03
All records of control and labeling associated with a batch of drug product were not maintained…
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 facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was InvaGen Pharmaceuticals, Inc. inspected by FDA?
This Form 483 is dated March 30, 2017.
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.