21 CFR 26.43 - Transmission of quality system evaluation reports.

Regulations last checked for updates: May 17, 2024

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

View all text of Subpart B [§ 26.31 - § 26.50]

§ 26.43 - Transmission of quality system evaluation reports.

Quality system evaluation reports covered by § 26.41 concerning products covered by this subpart shall be transmitted to the importing party within 60-calendar days of a request by the importing party. Should a new inspection be requested, the time period shall be extended by an additional 30-calendar days. A party may request a new inspection, for cause, identified to the other party. If the exporting party cannot perform an inspection within a specified period of time, the importing party may perform an inspection on its own.

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 26.43