FDA 483 - Jyoti Simple Solutions Private Limited - August 11, 2022

Jyoti Simple Solutions Private Limited, an intermediate manufacturer in Ahmedabad, Gujrat, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across its quality system, including inadequate procedures, lack of material testing, insufficient employee training, and poor record-keeping. These issues indicate a broad failure to adhere to cGMP requirements for the production of pharmaceutical intermediates.