LifeSouth Community Blood Centers, Inc
Form 483 issued February 27, 2020 · Gainesville, Florida
- Observations
- 4
- Pages
- 4
- FEI number
- 3003707120
In short: On February 27, 2020, FDA issued a Form 483 with 4 observations to LifeSouth Community Blood Centers, Inc in Gainesville, Florida (FEI 3003707120). Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are incomplete for cord blood units that fail specifications during stability testing and failed stability…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing. There are…
- 03
Not all deviations are assessed as part of the Annual Product Review to identify any adverse…
- 04
Pursuant to Section 704(b) of the Federal Food, Drug…
This inspection in context
Questions about this 483
What did FDA find at LifeSouth Community Blood Centers, Inc?
FDA listed 4 observations on this Form 483, mostly about quality system. 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.
When was LifeSouth Community Blood Centers, Inc inspected by FDA?
This Form 483 is dated February 27, 2020.
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.