Drugs

CGMP Violations at 2 United Exchange Facilities

An FDA 4/2-4/6/18 inspection at the United Exchange drug manufacturing facility in Cypress, CA, and a 4/4-4/6/18 inspection at the company’s facility in Rialto, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/6 Warning Letter says the specific violation was:

· failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, labeling, and drug products, including drug products manufactured, processed, packed, or held under contract by another company, and failing to establish adequate written responsibilities and procedures applicable to the quality control unit.

FDA reminds the company that it is responsible for the quality of its drugs regardless of agreements in place with contract facilities. The agency recommends that United Exchange engage a qualified consultant to assist it in meeting CGMP requirements. It also says the company must provide its quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality.

United was told to respond with a list of 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