FDA Inspection
AmLion Toothpaste Mfg SdnAmLion Toothpaste Mfg Sdn – FDA Inspection, Jul 14, 2023
Record Details
This FDA Inspection record concerns AmLion Toothpaste Mfg Sdn, with an inspection on July 14, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9f708434-ff04-4c2d-b58b-0e0067933e49
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1210002
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 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 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
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Other FDA inspections of AmLion Toothpaste Mfg Sdn
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | VAI | 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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