Drugs

CGMP Violations at RLC Labs

A 2/20-3/5 FDA inspection at RLC Labs, Phoenix, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/9 Warning Letter says the company also failed to fulfill its registration and listing obligations under the Federal Food, Drug, and Cosmetic Act. And it says that two of the firm’s drug products are adulterated for failing to conform to compendial standards for strength, quality, or purity. The letter lists these specific violations:

failure of the quality control unit to review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products the firm manufactures have the identity, strength, quality, and/or purity they purport or are represented to possess;
failing to follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
failing to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality; and
failing to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

The letter says that none of the firm’s products have a valid BLA or IND in effect.

Based on the nature of the violations identified at the firm, FDA says it strongly recommends that RLC engage a qualified consultant to assist it in meeting CGMP requirements.

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

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