FDA WARNING_LETTER - Dong Yuan Technology Co., Ltd. - September 28, 2018

The FDA issued a Warning Letter to Dong Yuan Technology Co., Ltd. following a September 24-28, 2018 inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated. The company failed to respond to the initial Form FDA 483 within 15 business days.

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(a) and (b)):** Assay methods for (b)(4) Spray OTC drug product were not shown to be equivalent or superior to USP 41 compendial methods. The firm also failed to follow its own SOP-LAB-002 by not testing the required number of samples and referencing an outdated MIL-STD-105E procedure. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** The manufacturing process for (b)(4) Spray was validated for batches up to (b)(4) units, but batches up to (b)(4) times larger were released. A (b)(4) bulk liquid hold time was also not evaluated during process validation. 3. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm did not retain complete laboratory data, only final results, and discarded records of sample weights and data from "bad