Drugs

CGMP, Other Violations at Acella Pharmaceuticals

A 12/17/19-1/7/20 FDA inspection at Acella Pharmaceuticals, Alpharetta, GA, found significant violations of current good manufacturing practice (CGMP) and other regulations in the firm’s production of finished drugs. An 8/14 Warning Letter says the firm’s NP Thyroid drug product is an unapproved adulterated drug and biologic product. Specific violations found were:

failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The letter says the agency sampled the firm’s NP Thyroid product and found low, out-of-specification results for both active ingredients. “We acknowledge that your firm did not distribute this lot from your contract warehouse and agreed to voluntarily destroy it,” FDA says.

The letter reminds Acella that it is responsible for the quality of its drugs regardless of contract facility agreements. And it recommends that the company contact the agency’s unapproved drugs coordinator for assistance in communicating with FDA on the application process for its unapproved biological product.

Acella 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