FDA Inspection
Endometriosis & Reproductive Surgery Specialists P.L.L.C.Endometriosis & Reproductive Surgery Specialists P.L.L.C. – FDA Inspection, Feb 5, 2010
Record Details
This FDA Inspection record concerns Endometriosis & Reproductive Surgery Specialists P.L.L.C., with an inspection on February 5, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 5, 2010
- Product Type
- Biologics
View Company Profile
ID · 9a510b89-da86-4255-8005-359220471898
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 645186
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.47(d)Departures: recording and justifying
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Endometriosis & Reproductive Surgery Specialists P.L.L.C.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 6, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 20, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 22, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 3, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Endometriosis & Reproductive Surgery Specialists P.L.L.C.
- FDA Inspection 1314404 - 2026-04-21
- FDA Inspection 1112551 - 2019-11-06
- FDA Inspection 1009745 - 2017-04-20
- FDA Inspection 935777 - 2015-06-22
- FDA Inspection 780153 - 2012-05-03
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