FDA Inspection
AmLion Toothpaste Mfg SdnAmLion Toothpaste Mfg Sdn – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns AmLion Toothpaste Mfg Sdn, with an inspection on March 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 076cc3f0-2470-48c9-b0b9-61761e1dfeca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042734
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.188(b)(4)Weights and Measures of Components Used
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 |
| June 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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