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Warning Letter Focuses on Use of Wrong Identity Test
Deltex Pharmaceuticals, a contract manufacturer specializing in liquids and semisolid dosage forms, was cited by the FDA in a warning letter for using the wrong identity test for incoming active pharmaceutical ingredients (APIs).
The company, based in Rosenberg, Texas, used the U.S. Pharmacopeia (USP) <197k> infrared spectrophotometric identity test for incoming lots of phenylephrine tannate, pyrilamine tannate and dextromethorphan tannate APIs. The USP <197K> identity test lacks the capability to detect physico-chemical changes of API raw materials or distinguish one API from another, the FDA says in the letter. The agency adds that it considers Deltex’s test method an inadequate analysis of the identification and quantitation of incoming tannate containing APIs.
In response to the Form 483 observations issued after the June 9 through July 15 inspection, the company told the FDA it would stop manufacturing all tannate products. |
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