FDA Inspection 898509 — Midwest Sperm Bank, LLC
The FDA completed an inspection of Midwest Sperm Bank, LLC on Oct 30, 2014 in Downers Grove, IL. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Downers Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |