FDA Inspection
VACT Healthcare SystemVACT Healthcare System – FDA Inspection, Mar 7, 2016
Record Details
This FDA Inspection record concerns VACT Healthcare System, with an inspection on March 7, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- VACT Healthcare System
- Inspection Date
- March 7, 2016
- Product Type
- Biologics
View Company Profile
ID · 54f4d568-4e51-4241-b24b-97aa2620da5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960958
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.121(b)Collection/initial processing facility labels
- 21 CFR 606.121(c)(13)Unapproved encoded/machine readable information
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VACT Healthcare System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2025 | Not classified | New England District Office | |
| August 2, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 27, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 30, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VACT Healthcare System
- FDA Inspection 1270265 - 2025-05-16
- FDA Inspection 1211525 - 2023-08-02
- FDA Inspection 1152185 - 2021-09-14
- FDA Inspection 1045149 - 2018-02-27
- FDA Inspection 864897 - 2014-01-30
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