NWL Netherlands Services B.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 failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 3

Your firm failed to perform identity testing of each component lot used in the production of your over-the-counter drug products, including **(b)(4)**, your active pharmaceutical ingredient. You also relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your component suppliers’ test analyses at appropriate intervals.

Passage 4

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).