Oct. 13, 2017

Vol. 9 No. 41

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FDA Cites Supplement Company for Drug Claims

A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More

Unapproved Ingredients Used by Washington State Compounder, FDA Says

A Washington state pharmacy used ingredients that are not covered by a designated monograph in compounding drugs, meaning it lost its exemption for labeling requirements, and also failed to maintain sanitary conditions for drug production, the FDA said in a warning letter. Read More

FDA Hits Devicemaker for Complaint Handling, Training, Records

Medicrea Technologies drew the FDA’s attention for inadequate complaint processing, employee training and material storage. Read More

Motion-Capture Company Failed to Report Camera Fix, FDA Says

A California photographic equipment company failed to file a required report with the FDA about a modification made to a camera to reduce a health risk in response to a customer complaint, the agency said in a Form 483 report. Read More