FDA Inspection 1234425 — Holmes By Products Co Inc
The FDA completed an inspection of Holmes By Products Co Inc on Mar 29, 2024 in Millersburg, OH. 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). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2024
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Millersburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 13556 | 21 CFR 589.2001(c)(1) | Contains cattle material prohibited in animal feed |
| 13568 | 21 CFR 589.2001(c)(2)(v) | Marking with readily detected agent |
| 21300 | 21 CFR 507.33(a) | Hazard Analysis |
| 21301 | 21 CFR 507.34(a)(1) | Preventive Controls |
| 21303 | 21 CFR 507.34(c)(1) | Process Controls |
| 21308 | 21 CFR 507.40 | Establishment and Implementation of Monitoring Preventive Controls |
| 21317 | 21 CFR 507.49(a)(1) | Calibration |
| 21320 | 21 CFR 507.49(a)(4) | Record Review |
| 21322 | 21 CFR 507.49(b)(1) | Written Calibration Procedures |
| 21560 | 21 CFR 507.36(a) | Customer Disclosure |