Drugs

CGMP Issues at Spain’s Proandre SL

A 6/11-6/14/18 FDA inspection at Proandre SL, a Barcelona, Spain, drug manufacturing facility, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/13 Warning Letter says specific violations 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 follow an adequate written testing program designed to assess the stability characteristics of drug products;
failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

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 it manufactures. The agency recommends that it retain a qualified consultant to assist in remediation efforts. Proandre was told to supply a comprehensive investigation into the extent of data record and reporting inaccuracies, including results of the data review for drugs distributed in the U.S.; a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; a management strategy including details of a global corrective and preventive actions plan; and a quality unit procedure with clearly defined responsibilities and procedures including approval and rejection authorities, second person verification, and yearly CGMP training covering good documentation practices and ALCOA (accurate, legible, contemporaneously recorded, original, attributable) principles.

FDA also recommended use of a consultant to meet CGMP regulations.

The agency says the firm’s OTC antibacterial soap liquid and hand sanitizer are misbranded due to labeling requirement violations.

Proandre was placed on an import alert 11/16/18. The company was told to respond with a list of specific actions 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