ScieGen Pharmaceuticals, INC.
Form 483 issued September 2, 2022 · Hauppauge, New York
- Inspection
- Aug 29 – Sep 2, 2022
- Investigator
- Sayyem H. Akbar
- Observations
- 2
- Pages
- 4
- FEI number
- 3008298016
In short: On September 2, 2022, FDA issued a Form 483 with 2 observations to ScieGen Pharmaceuticals, INC. in Hauppauge, New York (FEI 3008298016) after an inspection that ran Aug 29 – Sep 2, 2022. The investigator was Sayyem H. Akbar. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 02
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
This inspection in context
Sayyem H. Akbar
3 documents · 2022
Cites 211.113 (control of microbiological contamination) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ScieGen Pharmaceuticals, INC.?
FDA listed 2 observations 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 ScieGen Pharmaceuticals, INC.?
Sayyem H. Akbar is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was ScieGen Pharmaceuticals, INC. inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
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.