Rechon Life Science AB — 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). Your investigations into environmental monitoring (EM) excursion results and out-of- specification (OOS) assay results were inadequate. A. Your CAPAs to the persistent contamination of objectionable microorganisms were not robust, as evidenced by the…

Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). Your firm did not properly maintain classified areas and cleanrooms used in the manufacture of drug products. Our investigators observed peeling paint on the ceiling as well as bubbled paint and rust at the bottom of the door in ISO 7 room (b)(4) . Room (b)(4) provides access into aseptic filling line (b)(4) . These…

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)). You failed to ensure adequate aseptic behavior and establish appropriate written procedures designed to prevent microbiological contamination risks during the manufacture of drug products purported to be sterile…

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)). A. Your firm failed to validate and assess the effectiveness, distribution, and reproducibility of (b)(4) decontamination to ensure it can safely achieve a state of control in aseptic rooms against objectionable microorganisms. For example, your firm utilized (b)(4) as an (b)(4) decontamination of aseptic filling lines…