FDA Inspection
Haven ManufacturingHaven Manufacturing – FDA Inspection, Feb 7, 2019
Record Details
This FDA Inspection record concerns Haven Manufacturing, with an inspection on February 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5b4c1f7f-e263-4050-8c28-2523bbe7b832
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078512
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Haven Manufacturing
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | NAI | Compliance: Devices |
Other documents for Haven Manufacturing
- FDA Inspection 1305326 - 2026-03-20
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