Bioreliance Ltd.
Form 483 issued December 12, 2009 · Tampa, Florida
- Inspection
- Dec 3 – Dec 12, 2009
- Investigators
- Laurie A. Haxel· Luis A. Carrion
- Observations
- 4
- Pages
- 7
- FEI number
- 1122041
In short: On December 12, 2009, FDA issued a Form 483 with 4 observations to Bioreliance Ltd. in Tampa, Florida (FEI 1122041) after an inspection that ran Dec 3 – Dec 12, 2009. The investigators were Laurie A. Haxel and Luis A. Carrion. Most observations concern hCT/P.
At a glance
3 of 4 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures appropriate to meet cGMP requirements for all steps that you perform in the manufacturing of…
- 02
Information the relevant medical records of donors of HCT/Ps were not signed by a statement of…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures for facility cleaning and documentation were not followed. Specifically, no documentation of cleaning when the…
This inspection in context
Laurie A. Haxel
3 documents · 2008–2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Illinois.
The firmBioreliance Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioreliance Ltd.?
FDA listed 4 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected Bioreliance Ltd.?
Laurie A. Haxel and Luis A. Carrion are named on this Form 483, for the inspection of Dec 3 – Dec 12, 2009. Each investigator has a profile showing what they cite most.
When was Bioreliance Ltd. inspected by FDA?
The inspection ran Dec 3 – Dec 12, 2009, and the Form 483 is dated December 12, 2009.
How do I get the full Form 483 for Bioreliance Ltd.?
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.