FDA Inspection
Acon Laboratories, Inc.Acon Laboratories, Inc. – FDA Inspection, Jun 11, 2014
Record Details
This FDA Inspection record concerns Acon Laboratories, Inc., with an inspection on June 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Acon Laboratories, Inc.
- Inspection Date
- June 11, 2014
- Product Type
- Devices
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ID · 359d13d5-6f92-45c6-9ca5-b0d1d626990b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883470
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Acon Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Acon Laboratories, Inc.
- FDA Inspection 1172729 - 2022-05-10
- FDA Inspection 970553 - 2016-04-15
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