FDA Inspection
IBL Acquisitions LLCIBL Acquisitions LLC – FDA Inspection, Jan 18, 2018
Record Details
This FDA Inspection record concerns IBL Acquisitions LLC, with an inspection on January 18, 2018, issued by the Detroit District Office, covering medical devices & rad health.
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ID · 6e4b515b-161e-43e8-93cf-77dbd685b02c
Inspection Facts
- Inspection number
- 1038078
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of IBL Acquisitions LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for IBL Acquisitions LLC
- FDA Inspection 1123632 - 2020-03-11
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