Drugs

Kingston Pharma CGMP, Misbranding Violations

An 11/13-12/10/18 FDA inspection at the Kingston Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and misbranding violations. A 5/14 Warning Letter says specific violations were:

failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such procedures;
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;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates; and
failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

The letter says the company’s responses to the inspection observations were inadequate. FDA recommends that Kingston use consultants to assist it in meeting FDA requirements. The agency recommends that the consultants perform a comprehensive audit of the company’s entire manufacturing operations for CGMP compliance and evaluate implementation of corrective and preventive actions.

FDA also says that the company’s Resfriol-Ito Children’s Cold Cough & Sore Throat and Brosolvan are “drugs” as defined by the Federal Food, Drug, and Cosmetic Act and contain violative labeling and are misbranded.

Kingston was told to respond with specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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