FDA to Bar Imports from Indian Device Facility for CGMP, Misbranding Violations
The Food and Drug Administration will refuse imports of medical devices from Indian device manufacturer Shoney Scientific until misbranding and current good manufacturing practice violations are corrected, said the agency in a warning letter dated Nov. 20. FDA said an…
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inspection of Shoney’s Pondicherry facility revealed departures from CGMP including a failure to establish manufacturing equipment monitoring and calibration procedures. The letter also said one product manufactured at the facility, the “Disposable Biopsy Punch,” is misbranded because it is being marketed for an unapproved use. FDA exempts biopsy punches from premarket notification requirements as long as they are for general dentistry and oral surgery procedures, but Shoney’s website says that the device can also be used for “correcting vitiligo,” because “the smaller sizes of the biopsy punch are also used for hair transplant.”