FDA Inspection 1056647 — Germiphene Corporation
The FDA completed an inspection of Germiphene Corporation on May 24, 2018 in Brantford. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brantford (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |