Drugs

CGMP Violations at B. Jain Pharmaceuticals

David McFarland

— 1 min read
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An 8/13-8/29/18 FDA inspection at B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/21 Warning Letter says the specific violations were: 

  •          failing to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free from infestation by rodents, birds, insects, and other vermin;
  •          failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond official or other established requirements; and
  •          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 material, labeling, and drug products.

The letter says the firm’s responses to the inspection observations were inadequate or could not be assessed due to missing documentation of corrective activities. It also says the firm’s Relief Products Ring Relief, while represented as being a homeopathic drug, is a prescription drug as defined in the Federal Food, Drug, and Cosmetic Act, and is only safe for use under the supervision of a licensed practitioner and therefore is misbranded.

FDA acknowledges the firm has retained a third-party consultant and urges that it ensure that the consultant is qualified to assist it in meeting CGMP requirements. It recommends that the qualified consultant perform a comprehensive audit of the firm’s entire operations for CGMP compliance and that the consultant evaluate the completion and efficacy of corrective and preventive actions before B. Jain pursues resolution of its compliance status with FDA.

The company was placed on an import alert 1/9. It was told to respond with a list of steps taken since the FDA inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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