Marco Pharma International LLC – FDA Warning Letter, May 22, 2019

On January 10, 2020, the FDA issued a Warning Letter to Ms. Marx following an inspection of her facility in Roseburg, Oregon, from May 14-22, 2019. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products like Absinthium, Multi Somaplex, Molybdenum, and Manganese-Copper-Cobalt adulterated.

Key violations include: 1. **Failure to establish specifications (21 CFR 111.70(a))**: No specifications were established for incoming product identification, finished product packaging and labeling, or labels and packaging materials. Previous responses were inadequate. 2. **Lack of written quality control procedures (21 CFR 111.103)**: The firm failed to establish and follow written procedures for quality control operations, including material review and disposition decisions. The firm's ultimate responsibility for CGMP compliance, even with contract manufacturing, was emphasized. 3. **Deficient Master Manufacturing Records (MMRs) (21 CFR 111.210)**: MMRs for several products lacked required information, such as written instructions, sampling procedures, specific actions for process control, special notations, and corrective action plans. 4. **Incomplete Batch Production Records (BPRs) (21 CFR