Drugs

Polaroisin International CGMP Violations

A 9/11-9/15/17 FDA inspection at Polaroisin International, New Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/25 Warning Letter. Specific violations cited were:

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;
failing to ensure the identity of components, including active ingredients and excipients from various suppliers;
failing to ensure that its drug product bore an expiration date that was supported by appropriate stability testing; and
failing to establish 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.

The letter also notes that two of the firm’s products do not comply with provisions of the applicable over-the-counter drug monograph. “Based upon the nature of violations we identified at your firm,” FDA says, “we strongly recommend engaging a consultant to assist your firm in meeting drug CGMP requirements.”

The company was placed on import alert 1/8.

Polaroisin was told to respond with a list of specific 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