Topical product manufacturers receive one-third of FDA warning letters in FY 1996.
This article was originally published in The Tan Sheet
Executive Summary
TOPICAL PRODUCT MANUFACTURERS RECEIVED ONE-THIRD OF FY 1996 WARNING LETTERS from FDA for the year ended Sept. 30. Manufacturers of topical drugs were the recipients of 20 of the 59 warning letters issued by FDA during the fiscal year. Stability testing programs were a focal point of FDA concern; deficiencies in the stability area were addressed in more than two-thirds of the warning letters issued to topical manufacturing facilities.