JB Chemicals and Pharma Gujarat facility concludes USFDA inspection with zero observations
Gujarat: Pharma major, J.B. Chemicals & Pharmaceuticals Limited, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company’s formulations manufacturing facility- T20 located at Plot No. 4, GIDC, Panoli, Gujarat, with no observations.
The inspection was conducted from June 5, 2023 to June 9, 2023.
"At the end of the inspection, the facility received “No Observations” and thus NO Form 483 was issued," the company stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company remains committed to producing quality products, embedding a quality culture across the organization and continuously investing in systems, processes & training of its employees so that it can maintain the highest standards of quality and compliance for all its markets," J.B. Chemicals & Pharma stated.
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