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Hawkins, Inc., Minneapolis, Sept. 8 (Minneapolis).

Publication: Warning Letter Bulletin
Publication Date: 01-OCT-06 		Format: Online
Delivery: Immediate Online Access
Full Article Title: Hawkins, Inc., Minneapolis, Sept. 8 (Minneapolis).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

Article Excerpt
A March 28-31- and April 5-, 7- and 10-FDA investigation disclosed that Hawkins, which receives active pharmaceutical ingredients (API) from manufacturers and distributors, and subsequently repackages and re-labels them for further distribution for use by pharmacies for compounding of drug products, was in violation of current Good Manufacturing Practices (GMPs) for repacking and re-labeling of bulk drugs.

Deviations included, but were not limited to, failure to demonstrate the adequacy of the retest dating assigned to the 155 APIs that were repackaged by the firm for use by compounding pharmacies.

The firm routinely assigned, to its repackaged bulk drugs, retest dates that were either provided...

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