GMP Laboratories of America Inc – FDA 483, Jan 14, 2020

This FDA Form 483 was issued to R&C Laboratories of America Inc. in Anaheim, CA, following an inspection that identified significant deficiencies across multiple systems. The firm failed to follow quality control unit procedures, lacked adequate production and process controls including method validation, and exhibited issues with equipment maintenance and proper segregation of quarantined products. These observations indicate a general lack of adherence to current good manufacturing practices for homeopathic drug products.