FDA Sends Warning Letter to Illinois Manufacturer

In a warning letter dated Feb. 17, 2017, FDA detailed violations of current good manufacturing practices investigators found at Morton Grove Pharmaceuticals (a subsidiary of Wockhardt) during an FDA inspection conducted from Jan. 4–Feb. 5, 2016 at the company’s Morton Grove, IL facility. Several quality control issues were found by the investigators including failures to follow written procedures, data integrity problems, and incomplete laboratory data records.

Unexplained discrepancies or batch failures were not thoroughly investigated by the company, according to FDA. The company determined that impurities found would not cause health risks; however, they did not perform a science-based health hazard evaluation. The company’s determination of what caused stability failures was not explained and potentially affected batches were not investigated. FDA stated that the company must detail the phases of the root cause investigations and justify its decision to not investigate other batches.

FDA investigators found that the company had failed to ensure that laboratory records included complete data and that failed assay test results were “invalidated without scientific justification under the protocol and only re-test results were reported as part of batch release decisions. The original results were not reported or considered in evaluating the quality of your drugs for release.”

Quality control problems were also found, including quality investigations performed outside the quality unit’s oversight, a failure to establish and follow control procedures, and not testing in-process materials during production. Data integrity issues were also found. Appropriate controls over computer systems were not in place to ensure that only authorized personnel made changes to master production and control records.

The warning letter says that the violations found at the Morton Grove facility have been found at other Wockhardt facilities from 2013–2017. “At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with CGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs,” FDA stated. “In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.”

The agency requested that the company complete a data integrity remediation, a risk assessment of the potential effects of observed failures on the quality of product, and develop a corrective action and preventive action plan.

Source: FDA