FDA Inspection 1210002 — AmLion Toothpaste Mfg Sdn
The FDA completed an inspection of AmLion Toothpaste Mfg Sdn on July 14, 2023 in Petaling Jaya. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Petaling Jaya (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |