Fulijaya Manufacturing SDN. BHD.

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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Passage 2

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 3

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 4

Your firm did not have adequate stability data to demonstrate that the quality attributes of your drug products remain acceptable throughout the labeled expiry period. Assay testing for each active ingredient in your drug products was not being performed at each of your pre-determined timepoint intervals. Furthermore, your firm did not establish appropriate limits for impurities or evaluate your drug products for the presence of impurities.