Fougera Pharmaceuticals Inc.
Form 483 issued March 26, 2026 · Hicksville, New York
- Inspection
- Mar 23 – Mar 26, 2026
- Investigators
- Divek R. Jumani· Syeda N. Mahazabin
- Observations
- 1
- Pages
- 3
- FEI number
- 2410271
In short: On March 26, 2026, FDA issued a Form 483 with 1 observation to Fougera Pharmaceuticals Inc. in Hicksville, New York (FEI 2410271) after an inspection that ran Mar 23 – Mar 26, 2026. The investigators were Divek R. Jumani and Syeda N. Mahazabin. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Divek R. Jumani
5 documents · 2024–2026
Cites 211.100 (written procedures; deviations) 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 1 observation on this Form 483, mostly about facilities & equipment. 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.?
Divek R. Jumani and Syeda N. Mahazabin are named on this Form 483, for the inspection of Mar 23 – Mar 26, 2026. Each investigator has a profile showing what they cite most.
When was Fougera Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 23 – Mar 26, 2026, and the Form 483 is dated March 26, 2026.
How do I get the full Form 483 for Fougera Pharmaceuticals Inc.?
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