FDA Inspection
VitalantVitalant – FDA Inspection, Mar 24, 2010
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on March 24, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- March 24, 2010
- Product Type
- Biologics
View Company Profile
ID · 112c2d9e-7e04-4b62-a5e1-c60c0a2ca762
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652070
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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