FDA Inspection
Qualtex LaboratoriesQualtex Laboratories – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Qualtex Laboratories, with an inspection on September 15, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d1b8176e-b87d-4c1e-beb1-ff1bd91b8325
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025875
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.60(b)Equipment calibration frequency
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Qualtex Laboratories
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 27, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 27, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 21, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 20, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Qualtex Laboratories
- FDA Inspection 1251335 - 2024-09-27
- FDA Inspection 1122019 - 2020-02-27
- FDA Inspection 1122001 - 2020-02-27
- FDA Inspection 1028892 - 2017-09-21
- FDA Inspection 939930 - 2015-08-20
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