Medical Products Laboratories, Inc. – FDA EIR, Oct 12, 2017

Medical Products Laboratories, Inc. (MPL) was subject to an FDA inspection from October 2 to October 12, 2017. This comprehensive evaluation encompassed pre-approval, drug Good Manufacturing Practices (GMP), and a Level I Quality System Inspection Technique (QSIT) for medical devices, specifically focusing on a Glucose Tolerance Beverage. The inspection was conducted under established FDA guidelines for drug manufacturing and medical device inspections.

The inspection revealed significant deficiencies, predominantly within MPL's laboratory controls. An eight-item Form FDA-483 was issued to management. Key observations included inadequate calibration intervals for instruments, incomplete laboratory records lacking comprehensive data and precise sample measurements, and the use of equipment not meeting specifications. Further issues involved the absence of scientifically sound specifications and test procedures for in-process materials and drug products, insufficient periodic calibration records, and a lack of second-person review signatures on laboratory documentation. Additionally, employee training for assigned functions was deemed insufficient.

Beyond these formal observations, the FDA engaged management in discussions regarding several other laboratory concerns, such as safety in a quarantine area, low recovery rates in cleaning validation methods, analytical procedure inconsistencies, and a need for improved sample receipt and disposition protocols. MPL's management committed to implementing corrections for the FDA-483 observations and indicated they would consider the additional discussion points for improvement. No product samples were collected, and no inspection refusals occurred.