Fougera Pharmaceuticals Inc.
Form 483 issued November 17, 2023 · Hicksville, New York
- Observations
- 1
- Pages
- 2
- FEI number
- 2410271
In short: On November 17, 2023, FDA issued a Form 483 with 1 observation to Fougera Pharmaceuticals Inc. in Hicksville, New York (FEI 2410271). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Questions about this 483
What did FDA find at Fougera Pharmaceuticals Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Fougera Pharmaceuticals Inc. inspected by FDA?
This Form 483 is dated November 17, 2023.
How do I get the full Form 483 for Fougera Pharmaceuticals Inc.?
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