Drugs

Dabur India CGMP Violations

A 1/12-1/16 FDA inspection at a Dabur India Limited drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/24 Warning Letter says the specific violations were:

failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated;
failure to ensure that laboratory records included complete data derived from all tests to ensure compliance with established specifications and standards;
failure to establish and follow adequate written procedures for equipment cleaning and maintenance; and
failure to establish adequate written procedures for production and process control designed to ensure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess, and failure of the firm’s quality unit to review and approve the procedures, including any changes.

FDA acknowledges that the company recalled on 6/2 all redacted products due to systemic quality failures at the facility. However, it says that to date the company has not recalled other redacted products.

The agency recommends that Dabur retain a qualified consultant to evaluate its operations through a six-system audit, assist the firm in meeting CGMP requirements, and evaluate the completion and efficacy of the company’s corrective and preventive actions. FDA placed all of the company’s drugs and drug products on a 6/5 Import Alert.

Dabur was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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