483
Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) – FDA 483, Jun 12, 2026
Record Details
An FDA inspection of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) in Jinan, China, revealed significant deficiencies in their drug manufacturing operations. Observations included inadequate qualification of critical manufacturing equipment, failure to establish and follow proper production and process controls, and insufficient laboratory controls for reference standards. These issues indicate a lack of assurance regarding the identity, strength, quality, and purity of drug products.
- Inspection date
- June 12, 2026
- Product type
- drugs
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ID · 29452266-732f-432e-a667-3a65447eda2e
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