FDA 483 - Marlinz Pharma, LLC - May 04, 2022

An FDA inspection of Marlinz Pharma, LLC, an own label distributor in Houston, revealed significant deficiencies in the firm's quality system regarding customer complaint handling. The company failed to adhere to its own standard operating procedures for documenting and processing complaints. This resulted in incomplete complaint records, specifically missing critical information such as initial contact details and the nature of the complaint.