Significant GMP deviations were documented during a 3/25-29 FDA inspection of troubled Vintage Pharmaceuticals, according to a just-released 5/20 Warning Letter. Vintage had been under a consent decree for previous GMP violations, however, the decree expired late last year despite continuing problems that have been documented by FDA (see earlier story). The latest inspection revealed the firm’s inadequate process validation, failure to follow operating procedures for change controls and process validation, inadequate stability studies, and inadequate investigations of manufacturing and laboratory deviations.

To view the letter, visit http://www.fda.gov/foi/warning_letters/g3318d.htm