Excelvision Fareva — FDA Warning Letter Findings

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). You failed to adequately investigate customer complaints for the various sterile (b)(4) drug products (prescription and over-the-counter) you manufacture. Your investigations were not thorough, did not appropriately expand in scope, and lacked a…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Your air flow visualization studies (i.e., smoke studies) performed for your ISO 5 (Grade A) (b)(4) traditional aseptic filling line, used to fill (b)(4) drug products for the U.S. market, did not demonstrate…

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions and an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(v) and 211.42(c)(10)(vi)). Your aseptic processing operation is inadequately designed to prevent contamination of your sterile (b)(4) drug products. For example, the (b)(4) product ISO 5 (Grade A) filling line (b)(4) , is cleaned and…