Drugs

CGMP Violations at Global Treat

A 9/9-9/13/19 FDA inspection at Global Treat Srl, Galati, Romania, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/31 Warning Letter says specific violations were:

failing to perform, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
failing to establish an adequate quality control unit and failing to have in writing and follow the responsibilities and procedures applicable to the quality control unit.

The letter says the company’s responses to each of the inspection observations were inadequate. Also, the inspection found that one of the company’s products is defined as a drug in FDA regulations and is not labeled or formulated following the appropriate final rule for anorectal over-the-counter products.

FDA said it strongly recommends that Global retain a qualified consultant to assist it in meeting CGMP requirements. Global was placed on an import alert on 3/17.

The firm was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.

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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