kdc/one Chatsworth, 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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to establish and follow an adequate written stability testing program that included reliable, meaningful, and specific test methods for assessing the stability characteristics of these drug products (21 CFR 211.165(a) and 211.166(a)).

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 adequately investigate viscosity failures obtained during stability testing of distributed OTC drug products. Specifically, stability testing records documented **(b)(4)** out-of-specification (OOS) results without adequate root cause determination, CAPA, or documented justification for the established **(b)(4)** specifications.

Passage 4

Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)).