FDA Inspection 591208 — Hyland's Consumer Health Inc.
The FDA completed an inspection of Hyland's Consumer Health Inc. on Jun 22, 2009 in Los Angeles, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 22, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |