FDA Inspection
Stephen W. Welden,MD,PA dba Center for Reproductive MedicineStephen W. Welden,MD,PA dba Center for Reproductive Medicine – FDA Inspection, Mar 26, 2012
Record Details
This FDA Inspection record concerns Stephen W. Welden,MD,PA dba Center for Reproductive Medicine, with an inspection on March 26, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 26, 2012
- Product Type
- Biologics
View Company Profile
ID · 2ca8b75f-cca8-4173-bec2-72ae205ad217
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 774454
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.55(a)(1)Identification code affixed to container
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(c)Reproductive cells/tissues-Chlamydia, Neisseria
- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stephen W. Welden,MD,PA dba Center for Reproductive Medicine
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2015 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 16, 2014 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 15, 2013 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Stephen W. Welden,MD,PA dba Center for Reproductive Medicine
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.