OR WAIT 15 SECS
The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
FDA sent a warning letter to Wilson Medicine Company, dated Sept. 11, 2018, after inspectors found violations of current good manufacturing practice at the company’s Nandore, Palghar East, Thane, India facility. During the inspection, which was conducted from Feb. 26–March 1, 2018, inspectors observed a lack of written procedures for drug quality testing and equipment cleaning.
Specifically, the company failed to conduct process performance qualification and did not demonstrate that its processes were reproducible and controlled. Equipment qualification had also not been performed.
Analytical test methods-including assay, limit of nonvolatile residue, limit of preservative, and specific gravity-were not validated, according to FDA. “Although you committed to prepare an analytical method validation protocol by May 20, 2018, you did not specify a timeframe to complete method validation/verification or provide an interim plan of action,” the agency stated. The agency instructed the company to provide an independent assessment of all test methods, a plan of action to complete validation of analytical test methods, a review of its entire laboratory system, and a summary of test results obtained from testing retain samples of all drug products within expiry.
FDA also asked for an update on the company’s cleaning validation protocols for all manufacturing equipment. The company must also provide a risk assessment of the effect of its inadequate cleaning practices on product quality, a plan of action to ensure adequate cleaning, and an independent review of its facility to assess potential risks of cross-contamination.