FDA Inspection
GSB LLCGSB LLC – FDA Inspection, Feb 28, 2019
Record Details
This FDA Inspection record concerns GSB LLC, with an inspection on February 28, 2019, issued by the New Orleans District Office, covering medical devices & rad health.
- Person
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ID · ed2fe676-f799-4b2f-af71-70c6cb8f7747
Inspection Facts
- Inspection number
- 1080924
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of GSB LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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