FDA Inspection 1250014 — Sample Solutions, LLC
The FDA completed an inspection of Sample Solutions, LLC on Sep 25, 2024 in Olathe, CO. 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
- Sep 25, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olathe, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1419 | 21 CFR 211.42(c)(8) | Released Drug Products Area |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |