LifeSouth Community Blood Centers, Inc
Form 483 issued September 16, 2014 · Gainesville, Florida
- Inspection
- Sep 9 – Sep 16, 2014
- Investigators
- Simone E. Pitts· Susan M. Jackson
- Observations
- 13
- Pages
- 4
- FEI number
- 3003707120
In short: On September 16, 2014, FDA issued a Form 483 with 13 observations to LifeSouth Community Blood Centers, Inc in Gainesville, Florida (FEI 3003707120) after an inspection that ran Sep 9 – Sep 16, 2014. The investigators were Simone E. Pitts and Susan M. Jackson. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 8 of 13 observations.
Most cited: 21 CFR 211.22 (4×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to report a major change to the final product label for…
- 02
The firm does not have an ongoing stability protocol or stability data for cord blood units…
- 03
Change control program does not adequately capture all changes that impact cord blood operations such as…
- 04
The Quality Unit has not performed an annual product review for the period covered…
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
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 211.22
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 13 observations on this Form 483, mostly about quality system, production and biologics CGMP. 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?
Simone E. Pitts and Susan M. Jackson are named on this Form 483, for the inspection of Sep 9 – Sep 16, 2014. Each investigator has a profile showing what they cite most.
When was LifeSouth Community Blood Centers, Inc inspected by FDA?
The inspection ran Sep 9 – Sep 16, 2014, and the Form 483 is dated September 16, 2014.
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.