FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Slams Chinese OTC Maker for Serious Quality Violations

Feb. 27, 2019

The FDA hit Hangzhou SunKing Nonwovens with a warning letter, citing the manufacturer for numerous quality violations at its Hangzhou, Zhejiang facility.

The agency observed serious CGMP violations during an Aug. 7-9, 2018 inspection, including a failure to conduct proper quality testing before the release of OTC drug products.

The facility’s quality unit lacked written procedures for batch release, change control, complaints, recalls and annual product reviews.

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