Zermat International S.A. de C.V.

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 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 2

Your firm did not adequately investigate out-of-specification (OOS) results. Specifically, you released and distributed batches of over-the-counter (OTC) **(b)(4)** drug product lots# **(b)(4)** and **(b)(4)** with OOS results for viscosity without an investigation. Our review also noted that lot# **(b)(4)** was OOS for specific gravity and no further investigation occurred.

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 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 (21 CFR 211.100(a)).

Passage 5

You failed to adequately validate your manufacturing processes for **(b)(4)** produced in the **(b)(4)** filling line. You are responsible for assuring your manufacturing processes will consistently result in drug products meeting predefined quality attributes.