FDA Inspection
Huons Co., Ltd.Huons Co., Ltd. – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Huons Co., Ltd., with an inspection on August 21, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · c0575407-5d5c-41c5-bdee-158677a63087
Inspection Facts
- Inspection number
- 1331916
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
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