FDA Inspection
Texas Children's Hospital West CampusTexas Children's Hospital West Campus – FDA Inspection, Sep 30, 2015
Record Details
This FDA Inspection record concerns Texas Children's Hospital West Campus, with an inspection on September 30, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 30, 2015
- Product Type
- Biologics
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ID · f947213d-6e8e-45fe-b7a5-0a5d6f296cb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952020
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Legibility and indelibility
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Other FDA inspections of Texas Children's Hospital West Campus
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2025 | Not classified | Dallas District Office | |
| August 23, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 25, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Texas Children's Hospital West Campus
- FDA Inspection 1265759 - 2025-03-27
- FDA Inspection 1179519 - 2022-08-23
- FDA Inspection 1028291 - 2017-09-25
- FDA Inspection 822859 - 2013-03-19
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