FDA Inspection 785127 — Professional Complementary Health Formulas LLC
The FDA completed an inspection of Professional Complementary Health Formulas LLC on May 25, 2012 in Tualatin, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tualatin, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |