FDA Inspection
Healthbanks Biotech USA IncHealthbanks Biotech USA Inc – FDA Inspection, May 17, 2011
Record Details
This FDA Inspection record concerns Healthbanks Biotech USA Inc, with an inspection on May 17, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Healthbanks Biotech USA Inc
- Inspection Date
- May 17, 2011
- Product Type
- Biologics
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ID · 21a2c494-8878-4f0b-91d8-be213851bbb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723566
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.230(a)Process validation procedures
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Other FDA inspections of Healthbanks Biotech USA Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 15, 2010 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Healthbanks Biotech USA Inc
- FDA Inspection 1131595 - 2020-09-25
- FDA Inspection 1028798 - 2017-09-21
- FDA Inspection 637139 - 2010-01-15
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