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mercredi 25 mars 2020

WARNING LETTER DermaPharm A/S MARCS-CMS 596662 — MARCH 10, 2020

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 (2)).
Your firm receives raw material, "(b)(4)" as a component for use in production of (b)(4). This raw material is a (b)(4) containing (b)(4), the active ingredient in your finished drug product. Though you receive this raw material with a certificate of analysis from your supplier, you have not performed appropriate incoming analysis of component lots upon receipt, including confirming the identity prior to use in production of your finished drug product. You also relied on your supplier's Certificate of Analysis without establishing the reliability of your component supplier's test analyses at appropriate intervals.