Wockhardt Limited Receives FDA Warning Letter

FDA sent a warning letter to Wockhardt Limited on Dec. 23, 2016 following violations the agency found during a December 7–15, 2015 inspection of the company’s Gujarat facility. Violations observed during the inspection included deficiencies in sterile manufacturing and data integrity. Due to the violations, FDA placed the company on Import Alert 66-40 on August 5, 2016.

Sterile manufacturing observations

Specific sterile manufacturing violations mentioned in the letter included a failure to establish and follow written procedures for the prevention of microbiological contamination of products. Air flow disturbances were found by investigators and breaches in aseptic techniques were identified. FDA stated in the letter that the company should perform a review of all aseptic processing equipment design and aseptic techniques and provide a corrective actions and preventive actions (CAPA) plan.

Improper clothing worn by personnel, including gowns with unraveled stitching extending from hoods, zippers, and pants, was also observed. FDA stated in the letter that the company’s employees must use garments suitable for aseptic processing and was not satisfied with the company’s response to the observation.

“Your response is inadequate because it does not include your assessment of washing, drying, ironing, sterilizing, or other operations that may contribute to sterile garment damage. It also does not address the need to limit the number of sterilizations. Our investigator noted that you sterilize gowns numerous times. These excessive sterilizations lead to breakdown of gown fibers,” FDA stated.

Data integrity problems

Data integrity observations were also noted by the agency. Laboratory records did not include complete data from all tests, appropriate controls over data and records were not in place, and information regarding activities was not properly recorded.

Unreported testing results on raw materials, including out-of-specification (OOS) results, were found by FDA investigators. Computer systems were found to not be validated, and FDA asked the company to assess data generated from stability chambers, UV and infrared spectrophotometers, and TLC equipment.

Data, including sample preparation for OOS investigations and scale-up data, were recorded in unofficial notebooks found at the company. Some of the data in the notebooks were different from the official data, according to FDA. CGMP documentation was also discarded before the quality unit could assess the data. “Our investigator found torn and shredded equipment maintenance documents, raw material labels, and change control work orders in your scrap yard awaiting incineration. Your staff lacked knowledge of your corporate procedure for the destruction and incineration of documents,” FDA stated in the warning letter.

The agency asked the company to provide a comprehensive investigation of the data inaccuracies, a risk assessment of the data integrity failures on product quality, and a CAPA strategy.

Source: FDA