FDA Inspection 760394 — Hyland's Consumer Health Inc.
The FDA completed an inspection of Hyland's Consumer Health Inc. on December 14, 2011 in Los Angeles, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 14, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Los Angeles, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |