FDA Inspection
IntegraMed Medical Texas, PLLCIntegraMed Medical Texas, PLLC – FDA Inspection, Dec 13, 2013
Record Details
This FDA Inspection record concerns IntegraMed Medical Texas, PLLC, with an inspection on December 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 13, 2013
- Product Type
- Biologics
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ID · fe2b79a4-3914-4bc3-aa04-e9318e52861c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858696
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(c)Name and personal info on accompanying records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IntegraMed Medical Texas, PLLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2025 | Not classified | Dallas District Office | |
| April 2, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 13, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 26, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for IntegraMed Medical Texas, PLLC
- FDA Inspection 1261706 - 2025-02-12
- FDA Inspection 1085599 - 2019-04-02
- FDA Inspection 968356 - 2016-04-13
- FDA Inspection 677301 - 2010-08-26
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