FDA Inspection 1181688 — Haney, Inc.
The FDA completed an inspection of Haney, Inc. on October 18, 2022 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |