FDA Inspection
Healthbanks Biotech USA IncHealthbanks Biotech USA Inc – FDA Inspection, Jan 15, 2010
Record Details
This FDA Inspection record concerns Healthbanks Biotech USA Inc, with an inspection on January 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Healthbanks Biotech USA Inc
- Inspection Date
- January 15, 2010
- Product Type
- Biologics
View Company Profile
ID · 434adc1f-7a75-4c29-bebd-16eeafcefd57
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 637139
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.250(c)All labeling requirements met
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
Full citation text and observation details available on the Dashboard.
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 |
| May 17, 2011 | VAI | 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 723566 - 2011-05-17
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