FDA EIR - Medical Products Laboratories, Inc. - July 21, 2015

An FDA inspection of Medical Products Laboratories, Inc. in Philadelphia, PA, took place from July 14 to July 21, 2015. This routine surveillance inspection assessed the company's compliance with drug and medical device manufacturing regulations for its production of medical devices, human/animal drugs, and dietary supplements. The inspection revealed three significant objectionable conditions, documented on an FDA Form 483. A primary concern was the failure to follow and adequately document written production and process control procedures. Specifically, a manufacturing operator was observed performing unauthorized manual corrections to bottle caps on the Glucose Drink 100 production line without recording the issue or notifying management, and quality assurance personnel failed to detect this. Furthermore, critical operational parameters and equipment settings were not consistently documented in batch records. Another key issue involved inadequate laboratory controls, as standard solutions used for raw material chromatography testing lacked proper accuracy verification. Lastly, the company did not maintain an effective quarantine system for rejected components and drug product containers, raising concerns about preventing their unsuitable use. The company was required to address these findings and stated its intention to submit a written response to the district within 15 business days. This inspection highlighted the ongoing need for improved adherence to established procedures, particularly noting a repeat observation from a previous inspection.