USFDA warns Cadila on lack of audit trails, torn notebooks, product mix-ups,
Chennai: Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.
The United States Food and Drug Administration (USFDA) on December 23, 2014 had issued a warning letter to Cadila Healthcare for various deficiencies in its production process and documentation at its two plants in Gujarat.
The warning letter was addressed to Pankaj R Patel, chairman and managing director, Cadila Healthcare.
The USFDA found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
"Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records," the regulator said in its letter.
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