FDA Inspection
Houston Assisted Reproductive Technologies, PLLCHouston Assisted Reproductive Technologies, PLLC – FDA Inspection, Aug 7, 2026
Record Details
This FDA Inspection record concerns Houston Assisted Reproductive Technologies, PLLC, with an inspection on August 7, 2026, issued by the Dallas District Office, covering biologics.
- Inspection Date
- August 7, 2026
- Product Type
- Biologics
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ID · 53fc6d26-5f77-45ab-b9d6-6c4d8a98a2e1
Inspection Facts
- Inspection number
- 1329880
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(2)Risks associated with xenotransplantation
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Houston Assisted Reproductive Technologies, PLLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 29, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 27, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Houston Assisted Reproductive Technologies, PLLC
- FDA Inspection 1162284 - 2022-02-09
- FDA Inspection 1029763 - 2017-10-23
- FDA Inspection 898330 - 2014-09-29
- FDA Inspection 751556 - 2011-10-27
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