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BYD Precision Manufacture Co., Ltd manufactured surgical masks and N95 respirators that the FDA found to be adulterated due to failure to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The primary violation involved the company's failure to establish and maintain design control procedures, with no documented evidence of design input, output, review, verification, validation, transfer, changes, or design history files for their N95 respirator products. The inspection was conducted in May 2023 at the company's facility in Shenzhen, China, and the warning letter was issued in September 2023 following an inadequate response to the FDA's initial inspection observations.