LightEyez Limited

Selected passages from the FDA letter

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

Passage 1

Your firm failed to have adequate quality oversight responsibility over your manufacturer’s activities (e.g., further processing, use of water suitable for intended use) as required by 21 CFR 211.22(a).

Passage 2

Failure to address any violations may also result in the FDA refusing admission of articles manufactured by LightEyez into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).