Drugs

CGMP, Other Violations in Ningbo Pulisi Inspection

A 2/25-2/28 FDA inspection at Ningbo Pulisi Daily Chemical Products Co., Ltd., Yuyao City, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. An 8/13 Warning Letter says specific violations were:

failing to perform, 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 appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms;
failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failing to follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failing to establish written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

FDA says significant findings in the letter indicate that the company’s quality unit is not able to exercise its authority and/or responsibility. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality,” the letter says. “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in regulations to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.”

The letter also says several Ningbo products are misbranded because they are considered drugs under the Federal Food, Drug, and Cosmetic Act and the products’ labels do not meet requirements for over-the-counter drug labeling.

Ningbo Pulisi was placed on an FDA import alert 6/10. The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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