FDA Inspection
Smart World LLCSmart World LLC – FDA Inspection, Aug 22, 2017
Record Details
This FDA Inspection record concerns Smart World LLC, with an inspection on August 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2cba80a6-3c3d-465a-be56-ed7148cf2242
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022595
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.186QSR
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Smart World LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | San Francisco District Office | Project Evaluation: Devices |
| June 3, 2025 | VAI | San Francisco District Office | Drug Quality Assurance |
| September 15, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 10, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 10, 2019 | VAI | San Francisco District Office | New Drug Evaluation |
Other documents for Smart World LLC
- FDA Inspection 1322334 - 2026-06-05
- FDA Inspection 1275065 - 2025-06-03
- FDA Inspection 1180712 - 2022-09-15
- FDA Inspection 1122257 - 2020-03-10
- FDA Inspection 1085840 - 2019-04-10
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