IntelliCell Biosciences, Inc.
Form 483 issued December 12, 2011 · New York, New York
- Inspection
- Nov 8, 2011
- Investigator
- Irina Gaberman
- Observations
- 13
- Pages
- 6
- FEI number
- 3009237709
In short: On December 12, 2011, FDA issued a Form 483 with 13 observations to IntelliCell Biosciences, Inc. in New York, New York (FEI 3009237709) after an inspection that ran Nov 8, 2011. The investigator was Irina Gaberman. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 8 of 13 observations.
Most cited: 21 CFR 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedmes designed to prevent microbiological contamination of dmg products pmpmting to be sterile are…
- 02
Each batch of dmg product required to be free of objectionable tnicroorganisms is not tested…
- 03
There are no written procedures for production and process controls designed to assure that the dmg…
- 04
Established test procedures and laboratory control mechanisms are not followed and documented at…
This inspection in context
Irina Gaberman
8 documents · 2011–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmIntelliCell Biosciences, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IntelliCell Biosciences, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected IntelliCell Biosciences, Inc.?
Irina Gaberman is named on this Form 483, for the inspection of Nov 8, 2011. Each investigator has a profile showing what they cite most.
When was IntelliCell Biosciences, Inc. inspected by FDA?
The inspection ran Nov 8, 2011, and the Form 483 is dated December 12, 2011.
How do I get the full Form 483 for IntelliCell Biosciences, 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.