FDA WARNING_LETTER - Medisca Inc - February 27, 2014

This FDA Warning Letter (NYK-2016-12) was issued to Medisca Pharmaceutique, Inc. and Medisca, Inc. following a February 17-27, 2014, inspection of Medisca, Inc. in Plattsburgh, NY. The inspection was prompted by serious adverse event reports related to drug products compounded using Medisca's L-Citrulline active pharmaceutical ingredient (API).

FDA analysis of six L-Citrulline API samples revealed two were N-Acetyl-Leucine, a different amino acid. This led to the determination that Medisca's L-Citrulline APIs were adulterated under FDCA Section 501(c) due to incorrect strength, purity, and quality, and misbranded under Section 502(a) due to false and misleading labeling. The letter cites prohibited acts under FDCA Sections 301(a) and 301(k) for introducing adulterated/misbranded drugs into interstate commerce.

Medisca's March 7, 2014, response to the FDA 483 was acknowledged, as was their recall of eight L-Citrulline lots. FDA disagreed with Medisca's categorization of L-Citrulline as not an API, asserting its use as a bulk drug substance for compounding. The letter requests details on the extent of the product mix-