Drugs

Multiple CGMP Violations at Hong Kong Firm

FDA investigators found multiple violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in a 7/6-7/8/15 inspection at Chan Yat Hing Medicine Factory, Kowloon, Hong Kong, according to a just-released 12/15/15 Warning Letter. The letter says the firm did not respond to the inspection observations and was placed on a 12/3/15 import alert.

Specific violations cited in the letter included:
failing to test finished batches of drug products for active ingredient identity and strength; failing to ensure the identity of components, including active ingredients and excipients from various suppliers; failing to maintain data demonstrating that the products’ chemical and physical properties remain acceptable throughout their shelf life; failing to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess; failing to establish written responsibilities and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints; and failing to calibrate and maintain written records for the scale used to weigh components, including active ingredients, prior to their addition into the manufacturing process.

“Your quality unit releases multiple batches of drug products for distribution, despite these and other violations,” the letter says. “Based on the nature of the CGMP violations we identified at your firm, we recommend that you engage a third-party consultant with appropriate CGMP expertise to comprehensively assess your firm’s facilities, procedures, processes, laboratory controls, and quality management systems to ensure that the drug products you manufacture are consistently of appropriate identity, strength, quality, and purity.”

The firm was told to respond with a list of specific steps taken to correct the violations, documentation of each step, and a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome