Clement Clarke Intl., Ltd. FDA Record
- Latest inspection VAI · Oct 13, 2016
- No warning letters matched by name
Clement Clarke Intl., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Clement Clarke Intl., Ltd." is on file.
- Latest inspection
- Oct 13, 2016 · VAI
- Latest 510(k)
- Jan 31, 2006
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 | 6 | 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 |
|---|---|---|---|---|
| Oct 13, 2016 | Mountain Ash, United Kingdom | Devices | Voluntary Action Indicated (VAI) | 3002806708 |
- 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 3002806708 | Mountain Ash, United Kingdom | 1 | Oct 13, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Jan 31, 2006 |
| K042058 | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | Mar 23, 2005 |
| K000368 | EYECAP IMAGING SYSTEM | May 4, 2000 |
| K982334 | AIRZONE PEAK FLOWMETER | Jan 14, 1999 |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | Jun 10, 1998 |
| K962074 | VM PLUS PEAK FLOWMETER | Jan 2, 1997 |
Clement Clarke Intl., Ltd. and the FDA: common questions
Has Clement Clarke Intl., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Clement Clarke Intl., Ltd." 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 Clement Clarke Intl., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Clement Clarke Intl., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Clement Clarke Intl., Ltd.?
The most recent FDA inspection on file ended Oct 13, 2016 at Mountain Ash, United Kingdom and was classified VAI. FDA has 1 inspection of Clement Clarke Intl., Ltd. on file.
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