The FDA warned A-S Medication Solutions over failures to comply with the Food, Drug & Cosmetic Act’s drug listing requirements, following a May 2016 review.
A meeting with A-S CEO Walter Hoff and the firm’s attorney followed, during which the FDA outlined the deficiencies— including incorrect application names, incorrect proprietary names, inaccurate listings for package sizes, failures to include drugs’ DEA scheduling, incorrect carton labels and an incorrect listing of API strength. These errors put the company in violation of 21 CFR Part 207.
Based on the high error rate the FDA discovered in the listings, the agency concluded the errors and violations likely go deeper than those found by inspectors.
To prevent the dissemination of inaccurate information, all of the firm’s drug listing files will be removed from public view until the company corrects the files’ issues to the agency’s satisfaction, according to the FDA.