ScieGen Pharmaceuticals, INC.
Form 483 issued September 16, 2011 · Hauppauge, New York
- Inspection
- Sep 8 – Sep 16, 2011
- Investigators
- Neil J. Bonzagni· Robert C. Horan
- Observations
- 2
- Pages
- 1
- FEI number
- 3008298016
In short: On September 16, 2011, FDA issued a Form 483 with 2 observations to ScieGen Pharmaceuticals, INC. in Hauppauge, New York (FEI 3008298016) after an inspection that ran Sep 8 – Sep 16, 2011. The investigators were Neil J. Bonzagni and Robert C. Horan. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Neil J. Bonzagni
1 document · 2011
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 211.160
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 laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected ScieGen Pharmaceuticals, INC.?
Neil J. Bonzagni and Robert C. Horan are named on this Form 483, for the inspection of Sep 8 – Sep 16, 2011. Each investigator has a profile showing what they cite most.
When was ScieGen Pharmaceuticals, INC. inspected by FDA?
The inspection ran Sep 8 – Sep 16, 2011, and the Form 483 is dated September 16, 2011.
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.