FDA WARNING_LETTER - McCallum Manufacturing Ltd - July 26, 2017

On April 9, 2018, the FDA issued a Warning Letter to McCallum Manufacturing Ltd. following a July 24-26, 2017 inspection of their drug manufacturing facility in Barnsley, South Yorkshire, UK. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm released OTC drug product (b)(4) without adequate testing for identity and strength, lacking procedures, specifications, and analytical data. 2. **Inadequate component testing:** The firm failed to test incoming raw materials for identity, purity, strength, and quality, relying on supplier Certificates of Analysis (COA) without validation or conducting identity tests. 3. **Lack of a quality control unit:** The firm did not establish a quality control unit with authority to approve/reject materials and products, and lacked written procedures for quality operations like training, change control, and complaint handling. 4. **Absence of adequate production and process control procedures:** The firm lacked process validation for their OTC (b)(4) product and an ongoing monitoring program. 5. **Incomplete batch production and control records:** Records did not define and document process parameters, such as equipment identity, actual processing times, temperatures,