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§213.194. Laboratory records. — Inbound Citations

21 C.F.R. § 213.194

Cited by 1 regulation in release Current.

Citations to §213.194(a)(2)

  • (c) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 213.194(a)(2). The suitability of all testing methods shall be verified under actual conditions of use.