Company
United StatesSmart World LLC, Fremont, CA – FDA Inspections
Inspection records and compliance data for Smart World LLC in Fremont, California. 6 FDA inspections on record, 4 Form 483s, last inspected June 05, 2026.
Company Profile
This profile covers Smart World LLC based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 4
- Warning letters
- 0
First inspected August 22, 2017. Last inspected June 5, 2026.
Most cited issue areas
- Buildings not maintained in good state of repair1 inspection
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2026 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1322334 |
| June 3, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1275065 |
| September 15, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1180712 |
| March 10, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1122257 |
| April 10, 2019 | VAI | Human Drugs · New Drug Evaluation | 1085840 |
| August 22, 2017 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1022595 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Smart World LLC
FEI Number
3012448339
Address
48225 Lakeview Blvd, Fremont, California 94538, United States
Country
United States
ID: 58245a58-1141-4b8e-bdea-df100fec1aef