FDA Inspection 978459 — Trone Health Services, Inc.
The FDA completed an inspection of Trone Health Services, Inc. on July 15, 2016 in Meridian, ID. 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
- July 15, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Meridian, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4576 | 21 CFR 211.192 | No written record of investigation |