WARNING LETTER JHS Svendgaard Hygiene Products Ltd MARCS-CMS 593473 — FEBRUARY 13, 2020
1. Your firm failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(2)).
You lacked adequate testing of the incoming (b)(4) active pharmaceutical ingredient (API) to determine assay and other appropriate quality attributes. Instead, your firm relied on your suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.
You must test each component for conformity with appropriate written specifications for purity, strength, and quality unless and until you have appropriately qualified the suppliers and validated their test results at appropriate intervals...
2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Your firm lacked appropriate validation (or verification, for United States Pharmacopeia (USP) compendial methods) of your analytical test methods used to determine acceptability of your drug product before release for distribution.
Analytical methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility of your test methods is essential to determine if the drug products you manufacture meet established specification for chemical and microbial attributes...
