ScieGen Pharmaceuticals, INC.
Form 483 issued December 20, 2021 · Hauppauge, New York
- Inspection
- Dec 3 – Dec 20, 2021
- Investigators
- Gam S. Zamil· Vivin George
- Observations
- 1
- Pages
- 4
- FEI number
- 3008298016
In short: On December 20, 2021, FDA issued a Form 483 with 1 observation to ScieGen Pharmaceuticals, INC. in Hauppauge, New York (FEI 3008298016) after an inspection that ran Dec 3 – Dec 20, 2021. The investigators were Gam S. Zamil and Vivin George. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmScieGen Pharmaceuticals, INC. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ScieGen Pharmaceuticals, INC.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected ScieGen Pharmaceuticals, INC.?
Gam S. Zamil and Vivin George are named on this Form 483, for the inspection of Dec 3 – Dec 20, 2021. Each investigator has a profile showing what they cite most.
When was ScieGen Pharmaceuticals, INC. inspected by FDA?
The inspection ran Dec 3 – Dec 20, 2021, and the Form 483 is dated December 20, 2021.
How do I get the full Form 483 for ScieGen 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.