FDA Inspection 1147046 — Integrated Health Concepts Inc.
The FDA completed an inspection of Integrated Health Concepts Inc. on July 23, 2021 in San Luis Obispo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 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 |