Code of Federal Regulations · Section
§ 1002.13 — Annual Reports
21 C.F.R. § 1002.13
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(a) Every manufacturer of products requiring an annual report as specified in table 1 of § 1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by § 1002.30(a) and providing the volume of products produced, sold, or installed.
(b) Reports are due annually by September 1. Such reports shall cover the 12-month period ending on June 30 preceding the due date of the report.
Authorizing Statute
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Misbranded drugs and devices21 U.S.C. § 352