FDA Inspection
AmLion Toothpaste Mfg SdnAmLion Toothpaste Mfg Sdn – FDA Inspection, Jun 4, 2015
Record Details
This FDA Inspection record concerns AmLion Toothpaste Mfg Sdn, with an inspection on June 4, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AmLion Toothpaste Mfg Sdn
- Inspection Date
- June 4, 2015
- Product Type
- Drugs
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ID · 95ef0ba1-9c44-4741-92c0-b31d392106a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928841
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.125(e)Return of labeling
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
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Other FDA inspections of AmLion Toothpaste Mfg Sdn
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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