Drugs

RIJ Pharmaceutical Inspection Finds CGMP Issues

A 4/3-4/13/18 FDA inspection at RIJ Pharmaceutical, Middletown, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/28 Warning Letter says specific violations were:

failing to establish adequate written procedures for production and process control designed to assure that the drug products RIJ manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and failure of the firm’s quality control unit to review and approve the procedures, including any changes;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of 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;
failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures and to follow written procedures applicable to the quality control unit; and
failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The company was advised to retain a qualified consultant to assist in CGMP remediation and was told to submit to FDA (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting, including results of the data review for drugs distributed in the U.S.; (2) a current risk assessment of the potential effects of observed failures on the quality of the firm’s drugs; and (3) a management strategy for the firm that includes details of its global corrective and preventive action plan.

RIJ also was told to provide its quality unit with appropriate authority, sufficient resources, and staff to carry out its responsibilities to consistently ensure drug quality. And it 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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