21 CFR Part 606 · Current Good Manufacturing Practice for Blood and Blood Components

§ 606.165 Distribution and receipt; procedures and records

Subpart I - Records and Reports Official text on eCFR Amendment history

(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.

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What FDA inspectors cite under § 606.165

Form FDA 483 observations citing this section, fiscal years 2009–2015 (Biologics).

  • Distribution and receipt - recalls 5
  • Distribution records - content 3
  • Receipt records - content 1

FDA guidance that cites § 606.165

Amendment history

Federal Register documents that created or amended this section.