FDA Inspection
IT Synergistics, LLCIT Synergistics, LLC – FDA Inspection, Jun 23, 2020
Record Details
This FDA Inspection record concerns IT Synergistics, LLC, with an inspection on June 23, 2020, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- IT Synergistics, LLC
- Inspection Date
- June 23, 2020
- Product Type
- Biologics
View Company Profile
ID · 71f2c627-1e95-4d21-80d3-a13b2a036eaa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1124119
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of IT Synergistics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for IT Synergistics, LLC
- FDA Inspection 1180899 - 2022-09-07
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