FDA Inspection
VitalantVitalant – FDA Inspection, Feb 29, 2012
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on February 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- February 29, 2012
- Product Type
- Biologics
View Company Profile
ID · 25d2e8f5-fa1d-4d22-8767-be2c3e1e9529
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768506
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 211.22(c)Approve or reject procedures or specs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitalant
16| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | Not classified | Philadelphia District Office | |
| December 1, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 23, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1281129 - 2025-09-04
- FDA Inspection 1193237 - 2022-12-01
- FDA Inspection 1100311 - 2019-08-23
- FDA Inspection 1106128 - 2019-06-28
- FDA Inspection 1102324 - 2019-06-28
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