Drugs

Andapharm CGMP Repeat Violations

A 7/10-7/18 FDA inspection at Andapharm, Ft. Lauderdale, FL, found repeat violations of current good manufacturing practice regulations for finished pharmaceuticals. A 2/28 Warning Letter says specific violations were:

failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products;
failing to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups; and
failing to follow written procedures for production and process control designed to assure that drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and to document at the time of performance.

The letter says the first two violations are repeated from 2012 and 2016 inspections. The firm’s quality system is inadequate, FDA says, and it reminds the company it is responsible for the quality of drugs it produces as a contract facility, regardless of any agreement in place with product owners.

“Because you failed to correct repeat violations,” the letter says, “we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements.” The company 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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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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