FDA Inspection 1042734 — AmLion Toothpaste Mfg Sdn
The FDA completed an inspection of AmLion Toothpaste Mfg Sdn on March 2, 2018 in Petaling Jaya. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2018
- Fiscal Year
- 2018
- 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 |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |