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Granutec fails to "appropriately" investigate metal contamination in manufacturing -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

GRANUTEC FAILURE TO "APPROPRIATELY" INVESTIGATE METAL CONTAMINATION in its OTC drug manufacturing processes was cited by FDA in a Jan. 31 warning letter to the firm. The warning letter followed an inspection of the company's manufacturing plant between Dec. 21, 1994 and Jan. 9, 1995. The inspection was conducted as a follow-up to the company's recent acetaminophen recalls due to the presence of metal particles. Based in Wilson, N.C., Granutec manufactures private-label OTC analgesics and cold medications.
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