FDA WARNING_LETTER - Bio-Medical Pharmaceutical Manufacturing Corporation - August 29, 2025

The FDA issued a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation following an inspection from August 25 to 29, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) and the Federal Food, Drug, and Cosmetic Act, rendering the firm's drug products adulterated. Key issues include a failure to establish adequate procedures to prevent microbiological contamination in sterile drug products, lacking classified cleanrooms, appropriate aseptic conditions, and environmental controls. The company also failed to ensure proper design and maintenance of manufacturing equipment, notably their water system, and lacked essential process and cleaning validation studies. Furthermore, Bio-Medical did not conduct appropriate laboratory testing, including sterility testing, for drug product release, compromising product identity, strength, and purity. The firm also failed to fulfill drug listing obligations for its "(b)(4) Solution" product under 21 CFR 207. The FDA strongly recommended engaging a qualified CGMP consultant to evaluate operations and assist with compliance. Required actions include submitting comprehensive risk assessments, detailed remediation plans, system validation reports, and a corrective and preventive action (CAPA) plan for all identified violations within 15 working days. The company must also conduct full chemical and microbiological testing of retain samples for distributed products and clarify its intentions for manufacturing sterile drugs. Prompt correction is essential to avoid further regulatory or legal action.