Hikal Limited

Selected passages from the FDA letter

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

Passage 1

Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.

Passage 2

Your firm failed to implement effective CAPAs after receiving numerous complaints of foreign material contamination of your APIs. For example, a customer reported foreign material contamination involving eight lots of **(b)(4)** API. Your investigation found CAPAs were implemented for similar complaints prior to the manufacture of the complaint lots. However, our inspection found approximately 28 additional complaints reporting foreign material contamination after you completed your investigation.

Passage 3

Failure to have a system for evaluating suppliers of critical materials.

Passage 4

Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Hikal Limited, Jigani, 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).