FDA EIR - Medical Products Laboratories, Inc. - March 13, 2020

An FDA comprehensive surveillance and pre-approval inspection of Medical Products Laboratories, Inc. (MPL) was conducted in December 2019, assessing their manufacturing of prescription and over-the-counter human drugs, veterinary drugs, dietary supplements, medical devices, and cosmetics. The inspection followed regulatory frameworks including Drug Manufacturing and Pre-Approval Inspection Compliance Programs. The inspection resulted in an FDA Form 483 with five significant observations. Primary issues included inadequacies in the quality control unit's written procedures and adherence, and incomplete documentation of investigations into unexplained discrepancies, specifically lacking conclusions and follow-up actions. Detailed equipment cleaning and maintenance procedures were found to be deficient, particularly concerning methods, materials, and disassembly/reassembly instructions. Furthermore, the company failed to consistently record and justify deviations from written production and process control procedures. Finally, laboratory controls lacked scientifically sound specifications and test procedures crucial for ensuring the identity, strength, quality, and purity of in-process materials and finished drug products. Management assured the FDA that all identified deficiencies would be corrected. Discussions also encompassed the firm's handling of personal protective equipment, Standard Operating Procedure formatting, website content, and employee training programs.