FDA 483 - Shree Mahadev Intermediate - February 07, 2019

An FDA inspection of Shree Mahadev Intermediate in Ankleshwar, India, from February 5-7, 2019, resulted in a Form 483 with 10 observations. The firm demonstrated significant deficiencies across its quality systems, including a lack of written procedures, inadequate record keeping, insufficient employee training, and poor equipment and facility maintenance. These issues indicate a broad failure to comply with current good manufacturing practices for intermediate product manufacturing.