FDA Inspection 1193762 — Health Specialty
The FDA completed an inspection of Health Specialty on December 22, 2022 in Santa Fe Springs, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |