Sunstar Americas, Inc.

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 establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of its written production and process control procedures (21 CFR 211.100(a) and (b)).

Passage 2

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 3

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 4

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 5

Your firm failed to adequately validate a process whose results cannot be fully verified by subsequent inspection and test through established procedures (21 CFR 820.75(a)).

Passage 6

Failure to adequately establish schedules for the adjustment, cleaning, and other maintenance of equipment (21 CFR 820.70(g)).

Passage 7

Failure to adequately establish procedures for design input (21 CFR 820.30(c)).