FDA Inspection 1312680 — Scientific Pharmaceuticals, Inc.
The FDA completed an inspection of Scientific Pharmaceuticals, Inc. on Apr 15, 2026 in Pomona, CA. 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 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |