Sun Capsule, Inc. FDA Record
- Latest inspection VAI · Feb 1, 2018
- No warning letters matched by name
Sun Capsule, Inc. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sun Capsule, Inc." is on file.
- Latest inspection
- Feb 1, 2018 · VAI
- Latest 510(k)
- Mar 4, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 2 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 1, 2018 | Lawrence, MA | Devices | Voluntary Action Indicated (VAI) | 3011503793 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011503793 | Lawrence, MA | 1 | Feb 1, 2018 |
Sun Capsule, Inc. and the FDA: common questions
Has Sun Capsule, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Sun Capsule, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Sun Capsule, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Sun Capsule, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sun Capsule, Inc.?
The most recent FDA inspection on file ended Feb 1, 2018 at Lawrence, MA and was classified VAI. FDA has 1 inspection of Sun Capsule, Inc. on file.
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