FDA Inspection 1191662 — Hyland's Consumer Health Inc.
The FDA completed an inspection of Hyland's Consumer Health Inc. on Nov 29, 2022 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |