AmLion Toothpaste Mfg Sdn — FDA Facility Profile
AmLion Toothpaste Mfg Sdn is an FDA-inspected facility (FEI 3006057298) located in Petaling Jaya, MY. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jul 14, 2023: Official Action Indicated (OAI)
- Inspections on record
- 3 (1 OAI, 2 VAI)
- Last OAI inspection
- Jul 14, 2023
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 17, 2023
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 14, 2023 | Official Action Indicated (OAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Component identity verification (21 CFR 211.84(d)(1)) and 3 more |
| Mar 2, 2018 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Component identity verification (21 CFR 211.84(d)(1)) Valid stability test methods (21 CFR 211.166(a)(3)) and 2 more |
| Jun 4, 2015 | Voluntary Action Indicated (VAI) | Written procedures not established/followed (21 CFR 211.67(b)) Written calibration / inspection records not kept (21 CFR 211.68(a)) Actual vs. theoretical yields not determined (21 CFR 211.103) Return of labeling (21 CFR 211.125(e)) and 12 more |
Facility details
- Company
- AmLion Toothpaste Mfg Sdn
- Location
- Petaling Jaya (MY)
- Source
- inspections