Drugs

FDA Finds CGMP Violations in Originitalia Inspection

A 5/20-5/24 FDA inspection at the Originitalia SRL drug manufacturing facility in Vicenza, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/7 Warning Letter says specific violations were:

failure to test samples of each component for full identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of component supplier’s test analyses at appropriate intervals;
failure 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;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to establish and follow 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.

FDA says the firm has an ineffective quality system and executive management should immediately assess its manufacturing operations to ensure that the systems, processes, and products conform to FDA requirements.

The letter acknowledges the firm has ceased drug production and says the agency must be notified in advance if Originitalia decides to resume production. It recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Originitalia was told to promptly correct violations and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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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