§58.35. Quality assurance unit. — Inbound Citations
21 C.F.R. § 58.35
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 21 C.F.R. § 58.35 as a whole
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(c) Assure that there is a quality assurance unit as described in § 58.35.
Citations to §58.35(b)(7)
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(14) The statement prepared and signed by the quality assurance unit as described in § 58.35(b)(7).
Citations to §58.35(c)
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(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.