FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Hits Malaysian OTC Manufacturer for Multiple Deficiencies

Sept. 6, 2018

Malaysian OTC drug manufacturer AmLion Toothpaste drew a 483 for numerous quality violations including inadequate cleaning procedures.

After a Feb. 26-March 3 inspection, the FDA cited the company’s drug product stability program because it only required periodic tests of viscosity, pH, appearance and odor. The facility lacked stability data for some products and scientific justification for one product’s expiration date.

The agency also flagged the company’s storage conditions, observing that a warehouse used to store finished drug products, raw materials, packaging materials and other components had no temperature and humidity controls.

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