FDA 483 - Americare Compounding, LLC. - June 19, 2013

The FDA Form 483 details multiple deficiencies at a facility producing sterile injectable, sterile ophthalmic, and other drug products, including penicillin and beta-lactam non-penicillin drugs.

Key violations include: - **Laboratory Controls:** Inadequate sampling plans and test procedures. No assay or product identification testing for most sterile products. Sterility testing only for Avastin injectable syringe. No endotoxin testing data for any sterile lots. - **Stability Data:** Beyond Use Dates (BUDs) up to 30 days for sterile products are not supported by firm-conducted stability studies, relying solely on literature or vendor information. - **Sterilization Validation:** Sterilization processes (aseptic and/or terminally sterilized) have not been validated. No media fills/process simulations performed. - **Facility Separation:** Penicillin products (e.g., Penicillin Ophthalmic solution) are processed in the same cleanroom as non-penicillin products, and under the same air-handling system, creating contamination risk. Beta-Lactam non-penicillin drugs (e.g., Cefazidime) are processed on the same workstation as non-beta-Lactam drugs in the same cleanroom. - **Equipment Design/Environmental Control:** Lack of adequate environmental monitoring data to support ISO 5/7 conditions. Design limitations include an unclassified pass-through, lack of disinfection for incoming articles, and presence of non-