FDA Inspection 928841 — AmLion Toothpaste Mfg Sdn
The FDA completed an inspection of AmLion Toothpaste Mfg Sdn on June 4, 2015 in Petaling Jaya. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Petaling Jaya (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1549 | 21 CFR 211.125(e) | Return of labeling |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |