FDA Inspection 1251512 — Richard-Allan Scientific Company
The FDA completed an inspection of Richard-Allan Scientific Company on Apr 23, 2025 in Kalamazoo, MI. 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kalamazoo, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |