21 CFR 1270.35 - Specific records.
Records shall be maintained that include, but are not limited to:
(a) Documentation of results and interpretation of all required infectious disease tests;
(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;
(c) Documentation of the receipt and/or distribution of human tissue; and
(d) Documentation of the destruction or other disposition of human tissue.