FDA Issues Warning Letter to Indian Facility

FDA issued a warning letter to Emcure Pharmaceuticals on March 3, 2016 for CGMP violations that included poor aseptic processing techniques, sterilization practices, facility design, and environmental monitoring. The violations were observed during an FDA inspection that occurred from Jan. 27 to Feb. 4, 2015.

During their inspection, investigators observed a variety of poor aseptic processing techniques that included operators crawling on floors during routine aseptic filling operations, moving un-bagged sterilized tools from one area to another, dropping sterilized tools onto the floor and reusing them, operators with exposed skin, and operators using their bare hands to remove vials from the line. FDA states in the letter that the observed behavior violates the company’s Behavior and Aseptic Practices in Classified Areas procedures. FDA states the company also failed to follow Restricted Access Barrier Systems (RABS) loading patterns.

The FDA warning letter also expresses FDA’s concern that the company’s facility design may pose additional contamination risks to products. “For example, we observed an employee crawling under filling equipment to get to the area where he performed other critical operations. Collecting (b)(4) water from the bottom of the filling machine to lubricate equipment, as mentioned above, also raises concerns about the design and qualification of your equipment,” the letter states.

The company’s environmental monitoring and personnel monitoring data are also questioned. “Your environmental monitoring (EM) and personnel (PM) monitoring data are not reliable because of the materials and procedures you use to conduct EM and PM tests. Multiple elements of these programs are scientifically unsound.”

FDA also points to an inadequate visual inspection program. “Your qualification and re-qualification of operators did not include determining the operator’s ability to detect and identify known product defects for (b)(4) products or products filled in amber vials,” the letter states.

The warning letter states that FDA is asking the company to evaluate the extent of the inaccuracy of recorded and reported data, perform a risk assessment of the potential effects of the failure to ensure quality in products, and develop a corrective actions and preventive actions (CAPA) management strategy.

Source: FDA