Drugs

Amish Origins Marketing Unapproved Drugs: FDA

A 1/7-1/10 FDA inspection at the Amish Origins Management drug manufacturing facility in Worland, WY, found significant violations of current good manufacturing practice (CGMP) regulations in its manufacturing of unapproved and misbranded external analgesic and sunscreen products. A 5/28 Warning Letter says specific CGMP violations were:

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, before release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing as necessary;
failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of a component’s supplier’s test analyses at appropriate intervals;
failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also details the firm’s unapproved new drug and misbranded drug violations. It recommends that Amish Origins engage a qualified consultant to assist it in meeting CGMP requirements.

Amish Origins was told to correct violations promptly and to respond with a list of specific steps it has taken to address the 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