FDA Inspection 824415 — LifeSouth Community Blood Centers, Inc

LifeSouth Community Blood Centers, Inc — FEI 3001451318

The FDA completed an inspection of LifeSouth Community Blood Centers, Inc on Mar 27, 2013 in Gainesville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 27, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Gainesville, GA (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
22721 CFR 640.4(h)Storage temperatures after collection
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.