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# 7 Wockhardt Plants Now Violating CGMPs: FDA
- URL: https://www.fdaweb.com/7-wockhardt-plants-now-violating-cgmps-fda/
- Published: 2017-03-07T12:00:00.000Z
- Updated: 2026-09-14T22:10:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138138

FDA now considers seven of 12 India-based Wockhardt drug manufacturing sites to be out of compliance with current good manufacturing practice regulations (CGMP), according to a 2/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545133.htm?ref=fdaweb.com) from the agency’s Chicago District Office. The letter focuses on a 1/4-2/5/16 inspection at Wockhardt’s Morton Grove Pharmaceuticals facility in Morton Grove, IL, identifying the other six violative sites as Wockhardt Waluj (2013), Wockhardt Chikalthana (2013), Wockhardt Waluj (2013), CP Pharma (2016), Wockhardt Ankleshwar (2016), and Wockhardt Shendra 2017). The Morton Grove inspection found multiple violations, including: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch of any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
- failing to follow written procedures applicable to the quality control unit;
- failing to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
- failure of the quality control unit to test in-process materials during the production process; and
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.

The letter also says the firm failed to submit a field action report as required by regulations. And it reviews actions the agency has taken in response to CGMP violations and deviations at the other six Wockhardt facilities. “At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with CGMP,” it says. “These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs. 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…. 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.”

Morton Grove’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures, the letter says. The agency acknowledges that the company is using a consultant to audit its operations and assist in meeting FDA requirements. The company was told to provide **(1)** a comprehensive investigation into the extent of the inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and **(3)** a management strategy for the firm that includes details of its global corrective action and preventive action plan.

Morton Grove was told to correct the violations promptly and to respond with steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.