FDA Inspection
Acme United CorporationAcme United Corporation – FDA Inspection, Jul 19, 2013
Record Details
This FDA Inspection record concerns Acme United Corporation, with an inspection on July 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Acme United Corporation
- Inspection Date
- July 19, 2013
- Product Type
- Devices
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ID · e42fdf50-6275-43fe-9dc3-039f1c40027f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842096
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Acme United Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 24, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Acme United Corporation
- FDA Inspection 1120666 - 2020-03-13
- FDA Inspection 903440 - 2014-11-10
- FDA Inspection 709908 - 2011-02-08
- FDA Inspection 572481 - 2009-03-24
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