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# CGMP Violation in Emcure Inspection
- URL: https://www.fdaweb.com/cgmp-violation-in-emcure-inspection/
- Published: 2019-08-13T12:00:00.000Z
- Updated: 2026-09-15T01:43:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144754

A 2/11-2/20 FDA inspection at Emcure Pharmaceuticals, Maharashtra, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/emcure-pharmaceuticals-limited-576961-08022019?ref=fdaweb.com) says the specific violation was: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed.

The letter acknowledges the firm’s decision to recall the distributed sub-lots after discussion with FDA and the decision to install a sterility test isolator. FDA also acknowledged the Emcure commitment to conduct a further review of the failures and evaluate procedures for microbiological out-of-specification investigations to ensure they provide appropriate details in documenting root case as well as adequate impact assessments with respect to other lots or sub-lots that may be affected.

Emcure was told to submit **(1)** an assessment of its overall system for investigation of deviations, atypical events, complaints, out-of-specification results, and failures; **(2)** a comprehensive, third-party evaluation of records relating to discrepancies, deviations, complaints, maintenance, detailed batch defect history, and investigations related to potential sealing variability and container-closure integrity issues; and **(3)** its plans and procedures to ensure that future sterility failure investigations include a comprehensive evaluation of potential vulnerabilities in the manufacturing operation.

The letter notes that FDA cited similar CGMP observations in an 8/2017 inspection. “Your executive management remains responsible for fully resolving all deficiencies, and ensuring ongoing CGMP compliance,” FDA says. “You should immediately and comprehensively assess your company’s manufacturing operations to ensure that systems and processes and, ultimately, the products manufactured conform with CGMP requirements.”

The firm was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their occurrence, with a timetable for completion.