21 CFR 606.165: Distribution and receipt; procedures and records
Requires blood establishments to maintain distribution and receipt procedures and records that trace each unit to its consignee or source, including addresses, dates, quantities, lot or donor numbers, and expiration or collection dates, to enable recalls.
Part 606, Current Good Manufacturing Practice for Blood and Blood Components · Subpart I, Records and Reports
Recent 483s citing 606.165
See all 483s citing 606.165The regulation text
§ 606.165 Distribution and receipt; procedures and records.
(a)Distribution and receipt procedures shall include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall, if necessary.
(b)Distribution records shall contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s), the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient.
(c)Receipt records shall contain the name and address of the collecting facility, date received, donor or lot number assigned by the collecting facility and the date of expiration or the date of collection, whichever is applicable.
Questions
What does 21 CFR 606.165 require?
Requires blood establishments to maintain distribution and receipt procedures and records that trace each unit to its consignee or source, including addresses, dates, quantities, lot or donor numbers, and expiration or collection dates, to enable recalls.
Which sections are cited alongside 606.165?
In the same 483s, investigators most often also cite 606.100 (Standard operating procedures), 606.160 (Records), 606.170 (Adverse reaction file), 606.20 (Personnel).