Warning Letters

Review Warning Letters by infraction

Regulations

21 CFR 606.20(b) - (b) The personnel responsible for the collection, processing, compatibility testing, storage or d...

21 CFR 606.60(a) - (a) Equipment used in the collection, processing, compatibility testing, storage and distribution...

21 CFR 606.65(e) - (e) Supplies and reagents shall be used in a manner consistent with instructions provided by the ...

21 CFR 606.100(c) - (c) All records pertinent to the lot or unit maintained pursuant to these regulations shall be re...

21 CFR 606.165(b) - (b) Distribution records shall contain information to readily facilitate the identification of th...

21 CFR 610.40(b) - (b) Testing using one or more licensed, approved, or cleared screening tests. To perform testing...

21 CFR 610.40(a) - (a) Human blood and blood components

21 CFR 640.11(a) - (a) Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and ma...