Forcemech International LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately maintain a device master record to include, or refer to the location of, the packaging and labeling specifications, including methods and processes used, as required by 21 CFR 820.181(d).

Passage 2

Failure to establish and maintain procedures to control labeling activities as required by 21 CFR 820.120.

Passage 3

Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a).

Passage 4

Failure to adequately establish and maintain document control procedures, as required by 21 CFR 820.40.

Passage 5

Failure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a).

Passage 6

Failure to ensure that the label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR Part 830, as required by 21 CFR 801.20(a).

Passage 7

Failure to provide required information to Global Unique Device Identification Database (GUDID) as required by 21 CFR 830.300(a).