FDA Inspection
Inova Health Care ServicesInova Health Care Services – FDA Inspection, Feb 13, 2012
Record Details
This FDA Inspection record concerns Inova Health Care Services, with an inspection on February 13, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Inova Health Care Services
- Inspection Date
- February 13, 2012
- Product Type
- Biologics
View Company Profile
ID · be75d6aa-a20c-40ec-88b0-05382bcbde8f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 772364
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 640.3(b)(2)Qualifications of donor - blood pressure
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(9)Written methods for investigating adverse reactions
- 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 Inova Health Care Services
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2026 | Not classified | Baltimore District Office | Blood and Blood Products |
| September 4, 2024 | Not classified | Baltimore District Office | |
| August 7, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 19, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 24, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Inova Health Care Services
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.