FDA Inspection 1237258 — Avaria Health & Beauty Corp.
The FDA completed an inspection of Avaria Health & Beauty Corp. on April 30, 2024 in Cambridge. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 30, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |