Drugs

Italian Drug Firm Has CGMP Violations: FDA

A 6/19-6/23/17 FDA inspection at BBCOS srl, Cherasco, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a just-released 11/29/17 Warning Letter. Specific violations cited in the letter 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 sourced from various suppliers, including active ingredients;
failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to ensure that the firm’s drug product bore an expiration date that was supported by appropriate stability testing.

FDA says the company’s response did not commit to any corrective actions regarding the CGMP observations and instead stated that the company “will not be able for the time being to comply with USA good manufacturing practices for OTC pharmaceuticals” and “will therefore immediately cease to sell and ship to USA.”

The letter says that if the company intends to resume manufacturing drugs for the U.S. market, it should engage a qualified consultant to assist it in meeting CGMP requirements.

BBCOS was placed on an import alert 11/27/17. 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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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