Drugs

CGMP Violations at Bulgaria’s Ficosota

A 9/2-9/5/19 FDA inspection at Ficosota, Ltd., Shumen, Bulgaria, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/28 Warning Letter says specific violations were:

failing to have, 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 conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure of the quality control unit to exercise its responsibility to ensure that drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failing to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter says the company indicated it would not respond to each observation on an FDA-483 because it had stopped production for the U.S. market. FDA said the response was inadequate because it did not address the effect the violations may have on the company’s over-the-counter drug product within expiry and currently in the U.S. market.

FDA says that if Ficosota resumes drug manufacturing operations for the U.S. market it should engage a qualified consultant to perform a comprehensive audit of the company’s entire operation for CGMP compliance and assist the company in meeting CGMP requirements.

Ficosots was placed on FDA import alert 1/10. It was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the actions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome