ScieGen Pharmaceuticals, INC.
Form 483 issued January 9, 2015 · Hauppauge, New York
- Inspection
- Dec 29, 2014 – Jan 9, 2015
- Investigator
- Robert C. Horan
- Observations
- 1
- Pages
- 1
- FEI number
- 3008298016
In short: On January 9, 2015, FDA issued a Form 483 with 1 observation to ScieGen Pharmaceuticals, INC. in Hauppauge, New York (FEI 3008298016) after an inspection that ran Dec 29, 2014 – Jan 9, 2015. The investigator was Robert C. Horan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) 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 211.22(d)
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 quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected ScieGen Pharmaceuticals, INC.?
Robert C. Horan is named on this Form 483, for the inspection of Dec 29, 2014 – Jan 9, 2015. Each investigator has a profile showing what they cite most.
When was ScieGen Pharmaceuticals, INC. inspected by FDA?
The inspection ran Dec 29, 2014 – Jan 9, 2015, and the Form 483 is dated January 9, 2015.
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.