www.fdanews.com/articles/176375-form-483-unveils-a-slew-of-gmp-issues-at-wockhardt-plant
Form 483 Unveils a Slew of GMP Issues at Wockhardt Plant
April 27, 2016
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings.
FDA inspectors uncovered nine GMP violations at the company’s sterile and non-sterile manufacturing facility in Shendra Aurangabad, according to a Form 483 issued after a January inspection. At the time, Wockhardt CEO Habil Khorakiwala characterized the issues as “minor,” saying more than half of them could be resolved within a few weeks.
Findings from the 483 point to more substantive problems, including missing GMP records, untrained personnel and rejected API batches stored alongside approved ones.