FDA Inspection 1221867 — Empack Spraytech Inc.
The FDA completed an inspection of Empack Spraytech Inc. on Nov 3, 2023 in Brampton. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 3, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brampton (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |