21 CFR 606.20
Personnel
21 CFR 606.20 is the regulation titled “Personnel” in 21 CFR Part 606, Current Good Manufacturing Practice for Blood and Blood Components. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 606.100, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 606.20 most often, as written in the letters.
- 1 letterFailure of the personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components to have adequate training and experience, including professional training…
The regulation
Read the text of 21 CFR 606.20 (eCFR, as of Sep 1, 2026)
(a) [Reserved]
(b) The personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components shall be adequate in number, educational background, training and experience, including professional training as necessary, or combination thereof, to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess. All personnel shall have capabilities commensurate with their assigned functions, a thorough understanding of the procedures or control operations they perform, the necessary training or experience, and adequate information concerning the application of pertinent provisions of this part to their respective functions.
(c) Persons whose presence can adversely affect the safety and purity of the products shall be excluded from areas where the collection, processing, compatibility testing, storage or distribution of blood or blood components is conducted.
[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 606.20.
Latest letters citing it
The letter citing 21 CFR 606.20 that FDA posted most recently.
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