FDA Inspection
Acme Monaco CorporationAcme Monaco Corporation – FDA Inspection, Mar 7, 2014
Record Details
This FDA Inspection record concerns Acme Monaco Corporation, with an inspection on March 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Acme Monaco Corporation
- Inspection Date
- March 7, 2014
- Product Type
- Devices
View Company Profile
ID · 715dfc3e-70c8-4f68-9af4-40ae02d67de7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 870387
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Acme Monaco Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 17, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Acme Monaco Corporation
- FDA Inspection 1244038 - 2024-07-09
- FDA Inspection 1089531 - 2019-04-17
- FDA Inspection 982018 - 2016-08-24
- FDA Inspection 903178 - 2014-11-05
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