Code of Federal Regulations Title 21. Food and Drugs § 21.1.625 What records requirements must an accreditation body that has been recognized meet?

(a) An accreditation body that has been recognized must maintain electronically for 5 years records created while it is recognized (including documents and data) demonstrating its compliance with this subpart, including records relating to:

(b) An accreditation body that has been recognized must make records required by paragraph (a) of this section available for inspection and copying promptly upon written request of an authorized FDA officer or employee at the place of business of the accreditation body or at a reasonably accessible location. If the records required by paragraph (a) of this section are requested by FDA electronically, the records must be submitted to FDA electronically not later than 10 business days after the date of the request. Additionally, if the requested records are maintained in a language other than English, the accreditation body must electronically submit an English translation within a reasonable time.

(c) An accreditation body that has been recognized must not prevent or interfere with FDA's access to its accredited third-party certification bodies and the accredited third-party certification body records required by § 1.658.