FDA Inspection
Smart World LLCSmart World LLC – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns Smart World LLC, with an inspection on April 10, 2019, issued by the San Francisco District Office, covering human drugs.
- Person
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ID · 2107cb06-a0d3-4707-a3c4-f0c422fae066
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085840
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
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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 |
| August 22, 2017 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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 1022595 - 2017-08-22
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