Drugs

Multiple Violations at Trilogy Laboratories

An 8/22-8/27/19 FDA inspection at Trilogy Laboratories, Fort Myers, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A just-released 3/5 Warning Letter says specific violations were:

failing to perform, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to the final specifications for the drug product, including the identity and strength of each active ingredient, before release, and to conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms;
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 the component supplier’s test analyses at appropriate intervals; and
failing to establish adequate 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.

The letter also identifies new drug and misbranding violations for some Trilogy products. FDA acknowledges the company’s commitment to cease production of drugs at the facility and asks the company to clarify whether it intends to resume manufacturing drugs at the facility in the future.

Trilogy was told to take prompt action to correct the violations and FDA said it will schedule a face-to-face regulatory meeting to ensure that the company is taking prompt action. Trilogy 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 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