Drugs

Milbar Laboratories CGMP Violations

A 12/7-12/27/17 FDA inspection at Milbar Laboratories, East Haven, CT, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/23 Warning Letter says specific violations were:

failing 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;
failing to reject any lot of components that did not meet the appropriate written specification for identity, strength, quality, and purity;
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 has already been distributed; and
failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

The letter notes that similar observations were made during 1/2010, 3/2013, and 4/2016 inspections. “Your firm’s failure to remediate these deficiencies demonstrates that management oversight and control over drug manufacturing is inadequate,” it says. “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements. We also recommend that the qualified third party perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the effectiveness of your corrective actions and preventive actions.”

Milbar was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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