RTI Biologics, Inc.
Form 483 issued July 11, 2012 · Alachua, Florida
- Inspection
- Jun 25 – Jul 11, 2012
- Investigator
- Grecek Trinh
- Observations
- 6
- Pages
- 7
- FEI number
- 3002719998
In short: On July 11, 2012, FDA issued a Form 483 with 6 observations to RTI Biologics, Inc. in Alachua, Florida (FEI 3002719998) after an inspection that ran Jun 25 – Jul 11, 2012. The investigator was Grecek Trinh. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.195 (environmental control and monitoring).
At a glance
6 of 6 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Environmentat ·conditioris existed in· which contamination or cross contamination ofHCT/Ps or equipment could occur, and envirorunental…
- 02
Environmental controls do not provide for adequate cleaning and disinfecting of rooms and equipment…
- 03
Corrective actions relating to core CGTP requirements did not include both short term corrective actions to…
- 04
Processes whose results could not be fully verified by inspection and tests, were not validated and…
This inspection in context
Grecek Trinh
1 document · 2012
Cites 1271.195(a) (environmental control and monitoring) more than any other section. Most of their documents are for sites in Florida.
The firmRTI Biologics, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.195(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RTI Biologics, Inc.?
FDA listed 6 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.195 (environmental control and monitoring). The opening words of each observation are shown on this page.
Who inspected RTI Biologics, Inc.?
Grecek Trinh is named on this Form 483, for the inspection of Jun 25 – Jul 11, 2012. Each investigator has a profile showing what they cite most.
When was RTI Biologics, Inc. inspected by FDA?
The inspection ran Jun 25 – Jul 11, 2012, and the Form 483 is dated July 11, 2012.
How do I get the full Form 483 for RTI Biologics, 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.