LifeSouth Community Blood Centers, Inc
FDA inspection history in Gainesville, Florida, 2003 to 2020
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2003: one warning letter; 2014: one Form 483; 2018: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2003One warning letter, at Gainesville, Florida.
- 2014One Form 483, at Gainesville, Florida.
- 2014The longest 483 on file: 13 observations over 4 pages at Gainesville, Florida.
- 2018–20Two Form 483s, at Gainesville, Florida.
Cited most
Across all LifeSouth Community Blood Centers observations on file
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.180General requirements3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
The complete LifeSouth Community Blood Centers file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Gainesville, Florida
Three Form 483s and one warning letter · 2003 to 2020 · 25 observations
Latest: Form 483, Feb 27, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-27 | 483 Form 483 | Gainesville, Florida | — | $99 |
| 2018-07-24 | 483 Form 483 | Gainesville, Florida | 12 | $99 |
| 2014-09-16 | 483 Form 483 | Gainesville, Florida | 13 | $99 |
| 2003-09-26 | Warning letter Warning letter | Gainesville, Florida | — | $99 |
Investigators on these documents
Justin A. Boyd (1)Mercy O. Quagraine (1)Simone E. Pitts (1)Susan M. Jackson (1)
FEI number 3003707120 · most recent document Feb 27, 2020
About LifeSouth Community Blood Centers, Inc
How many FDA Form 483s has LifeSouth Community Blood Centers, Inc received?
FDA Intel has 3 Form 483s on file for LifeSouth Community Blood Centers, Inc; the most recent is dated Feb 27, 2020.
When was LifeSouth Community Blood Centers, Inc last inspected by FDA?
The most recent FDA inspection document on file for LifeSouth Community Blood Centers, Inc is a Form 483 dated Feb 27, 2020, for the site in Gainesville, Florida.
What did FDA cite at LifeSouth Community Blood Centers, Inc?
The regulations cited most in the observations on file for LifeSouth Community Blood Centers, Inc are 21 CFR 211.22 (Responsibilities of quality control unit), 7 times; 21 CFR 211.180 (General requirements), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.
Has LifeSouth Community Blood Centers, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for LifeSouth Community Blood Centers, Inc; the most recent is dated Sep 26, 2003.