FDA Inspection 1070095 — VitaCare Labs Inc.
The FDA completed an inspection of VitaCare Labs Inc. on Oct 26, 2018 in Mississauga. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |