FDA Inspection 774454 — Stephen W. Welden,MD,PA dba Center for Reproductive Medicine
The FDA completed an inspection of Stephen W. Welden,MD,PA dba Center for Reproductive Medicine on March 26, 2012 in Lutz, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 26, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lutz, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12234 | 21 CFR 1271.55(a)(1) | Identification code affixed to container |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12249 | 21 CFR 1271.55(d)(3) | Records not made available to FDA |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12281 | 21 CFR 1271.75(c) | Reproductive cells/tissues-Chlamydia, Neisseria |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |