FDA Inspection 1147046 — Integrated Health Concepts Inc.
The FDA completed an inspection of Integrated Health Concepts Inc. on Jul 23, 2021 in San Luis Obispo, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 23, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Luis Obispo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18951 | FDCA 501(a)(2)(A) | Personnel contact outside ISO 5 area |