FDA Inspection
VitalantVitalant – FDA Inspection, Mar 13, 2009
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on March 13, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- March 13, 2009
- Product Type
- Biologics
View Company Profile
ID · e0f3ef26-c592-4fa2-be64-921bf0b48e3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 576044
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65Safe, sanitary, orderly storage
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Vitalant
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | VAI | Denver District Office | Blood and Blood Products |
| September 24, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 7, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1260274 - 2025-02-07
- FDA Inspection 1106655 - 2019-09-24
- FDA Inspection 1023598 - 2017-08-31
- FDA Inspection 983419 - 2015-10-20
- FDA Inspection 900184 - 2014-10-07
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