Drugs

CGMP Violations at Guangdong Zhanjiang Jimin

David McFarland

— 2 min read
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A 5/15-5/19 FDA inspection at Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhanjiang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/30 Warning Letter. The letter says the firm also manufactures and distributes a product for over-the-counter use that violates two sections of the Federal Food, Drug, and Cosmetic Act. Specific violations cited in the letter 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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release; and
  •          failing to establish adequate 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.

According to FDA, the firm’s response to the inspection observations was inadequate and did not provide sufficient evidence of corrective actions to bring its operations into compliance with CGMP. The agency says it strongly recommends engaging a qualified consultant to assist Guangdong in meeting CGMP requirements.

The letter says the firm’s Piyanping Anti-Itch Lotion product that claims to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes is considered to be a drug and is not formulated in accordance with the tentative final monograph for external analgesic drug products for OTC human use. It says the firm’s product is labeled for hydrocortisone 1% as its active ingredient, but the active ingredient actually is dexamethasone acetate. FDA says the lotion product is considered to be a new drug and is misbranded because its labeling is false and misleading due to the different formulation.

The agency also says the firm’s Shennong Analgesic Plaster includes the active ingredient methyl salicylate at a dosage range of 1.4%, below the 10-60% proposed in the tentative final monograph.

The company was placed on Import Alert 8/21.

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

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