Fougera Pharmaceuticals Inc.
Form 483 issued August 10, 2022 · Hicksville, New York
- Inspection
- Jul 18 – Aug 10, 2022
- Investigator
- Karishma G. Gopaul
- Observations
- 2
- Pages
- 3
- FEI number
- 2410271
In short: On August 10, 2022, FDA issued a Form 483 with 2 observations to Fougera Pharmaceuticals Inc. in Hicksville, New York (FEI 2410271) after an inspection that ran Jul 18 – Aug 10, 2022. The investigator was Karishma G. Gopaul. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent that would alter…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Karishma G. Gopaul
8 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmFougera Pharmaceuticals Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fougera Pharmaceuticals Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Fougera Pharmaceuticals Inc.?
Karishma G. Gopaul is named on this Form 483, for the inspection of Jul 18 – Aug 10, 2022. Each investigator has a profile showing what they cite most.
When was Fougera Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jul 18 – Aug 10, 2022, and the Form 483 is dated August 10, 2022.
How do I get the full Form 483 for Fougera 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.