LifeSouth Community Blood Centers, Inc
Form 483 issued July 24, 2018 · Gainesville, Florida
- Inspection
- Jul 17 – Jul 24, 2018
- Investigators
- Justin A. Boyd· Mercy O. Quagraine
- Observations
- 12
- Pages
- 6
- FEI number
- 3003707120
In short: On July 24, 2018, FDA issued a Form 483 with 12 observations to LifeSouth Community Blood Centers, Inc in Gainesville, Florida (FEI 3003707120) after an inspection that ran Jul 17 – Jul 24, 2018. The investigators were Justin A. Boyd and Mercy O. Quagraine. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The reserve sample of drug product does not consist of at least twice the quantity necessary…
- 02
Biological product deviations were not reported within the…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The quality control unit lacks authority to review production records to assure that…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmLifeSouth Community Blood Centers, Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LifeSouth Community Blood Centers, Inc?
FDA listed 12 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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 LifeSouth Community Blood Centers, Inc?
Justin A. Boyd and Mercy O. Quagraine are named on this Form 483, for the inspection of Jul 17 – Jul 24, 2018. Each investigator has a profile showing what they cite most.
When was LifeSouth Community Blood Centers, Inc inspected by FDA?
The inspection ran Jul 17 – Jul 24, 2018, and the Form 483 is dated July 24, 2018.
How do I get the full Form 483 for LifeSouth Community Blood Centers, 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.