The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility.
The investigator found that procedures were not in place to validate manufacturing processes that could cause variability in products. The hold-time studies for certain tablets were not performed as required, and the dispensing quarantine hold-time study was not evaluated.
The firm’s test methods for analyzing the stability of samples were found to be inadequate. Forced degradation studies were not performed under a variety of conditions to determine their stability.
The agency also flagged deficiencies in the facility’s quality control unit. Numerous documents listed in a standard operating procedure were to be kept confidential and controlled by the quality assurance unit, according to the SOP. Instead, multiple documents and a notebook containing classified data were found on the facility floor and in an unlocked cabinet in the warehouse office.
Drug products were also improperly stored to ensure their quality was not impacted by temperature and humidity. The finished product warehouse’s temperature was inadequately mapped to ensure satisfactory conditions.
In addition, the firm had no hot water in its restrooms, the cold water lacked adequate pressure for employees to wash their hands, and sanitization records were not displayed in the bathrooms.