Midwest Fertility Specialists FDA Inspection Record
Midwest Fertility Specialists is an FDA-inspected facility (FEI 3005620323) located in Carmel, IN, US. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 25, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (2 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 25, 2024 | Voluntary Action Indicated (VAI) | Testing, screening, donor eligibility procedures (21 CFR 1271.47(a)) Risk factors, clinical evidence (21 CFR 1271.75(a)(1)) |
| Oct 16, 2019 | No Action Indicated (NAI) | No citations listed |
| Jun 21, 2017 | No Action Indicated (NAI) | No citations listed |
| Jun 18, 2015 | No Action Indicated (NAI) | No citations listed |
| Jan 31, 2013 | Voluntary Action Indicated (VAI) | Responsible person to determine, document (21 CFR 1271.50(a)) Name and personal info on accompanying records (21 CFR 1271.55(c)) Accurate, indelible, legible (21 CFR 1271.55(d)(2)) Eligibility not required--warning labels (21 CFR 1271.90(c)) |
| Apr 19, 2010 | No Action Indicated (NAI) | No citations listed |
Form 483s and inspection documents
Facility details
- Company
- Midwest Fertility Specialists
- Location
- Carmel, IN (US)
- Source
- inspections