Sanapac GMP deficiencies
This article was originally published in The Tan Sheet
Executive Summary
Outlined by FDA in an April 19 letter to Dallas, Penn.-based Sanapac Co., problems include failure to package iron supplements in solid oral dosage form in unit-dose packaging. The company, which distributes products primarily on the East Coast, is recalling its products and adding child-proof caps to containers. Sanapac's iron-containing products include Sanapac Rooster brand pills, Rooster Kings, Super Kings Inner Man, Sanapac Inner Man Gold and Super Queens Inner Woman. FDA inspected the company's repackaging and distribution facility on Feb. 11. The agency also notes the company's dietary supplements are misbranded because their labeling bears National Drug Code listing numbers