FDA WARNING_LETTER - Marcus Research Laboratory, Inc. - May 14, 2021

The FDA issued a Warning Letter to Marcus Research Laboratory, Inc. following an inspection from May 3-14, 2021, which identified significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to ensure API quality and purity:** The Quality Unit (QU) released Povidone Iodine (PVP-I) lots 100017872R and 100017911C despite critical incidents (smoldering/smoking reactors, fire extinguisher use) that exposed the API to excess heat, fire, smoke, and potential contamination from debris or extinguisher chemicals. The firm only tested for available iodine and lacked comprehensive investigations, risk assessments, or additional testing for contaminants. The firm's response was deemed inadequate for not providing supporting documentation. 2. **Inadequate equipment surfaces:** Critical manufacturing equipment (blender, hoppers) had discolored and rusty product contact surfaces, requiring third-party corrosion removal, indicating potential product contamination (e.g., rust). Additionally, tattered and torn plastic liners used during processing exposed PVP-I to plastic particulate matter. The firm's response regarding corrosion removal was inadequate due to lack of scientific justification. These issues were previously raised in 2019 and 2020.

The FDA recommends engaging a qualified CGMP consultant to audit