21 CFR 26.13 - Transmission of postapproval inspection reports.

Regulations last checked for updates: May 17, 2024

Title 21 - Food and Drugs last revised: May 15, 2024

View all text of Subpart A [§ 26.1 - § 26.21]

§ 26.13 - Transmission of postapproval inspection reports.

Postapproval good manufacturing practice (GMP) inspection reports concerning products covered by this subpart will be transmitted to the authority of the importing country within 60-calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90-calendar days of the request.

authority: 5 U.S.C. 552; 15 U.S.C. 1453,1454,1455; 18 U.S.C. 1905; 21 U.S.C. 321,331,351,352,355,360,360b,360c,360d,360e,360f,360g,360h,360i,360j,360l,360m,371,374,381,382,383,393; 42 U.S.C. 216,241,242l,262,264,265

source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.

cite as: 21 CFR 26.13