Drugs

Nox Bellow Cosmetics CGMP Violations

A 9/18-9/22/17 FDA inspection at Nox Bellcow Cosmetics, Guandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/9 Warning Letter. Specific violations cited 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 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 component supplier’s test analysis at appropriate intervals;
failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards; and
failing to ensure that drug products bear an expiration date supported by appropriate stability testing.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures. FDA recommends that the company retain a qualified consultant to assist in its remediation and provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and (3) a management strategy that includes details of a global corrective and preventive action plan.

FDA also says that significant findings in the letter indicate that the firm’s quality unit is not able to fully exercise its authority and/or responsibilities and that the unit must be provided the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.

The company was placed on an import alert 12/27/17. Nox Bellow was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with 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