FDA Inspection
Custom Assemblies, Inc.Custom Assemblies, Inc. – FDA Inspection, Sep 1, 2011
Record Details
This FDA Inspection record concerns Custom Assemblies, Inc., with an inspection on September 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Custom Assemblies, Inc.
- Inspection Date
- September 1, 2011
- Product Type
- Devices
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ID · d27fb2c9-8542-4e52-81c5-7da97fe58d1b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 746143
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Custom Assemblies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 6, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 19, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Custom Assemblies, Inc.
- FDA Inspection 1277633 - 2025-07-24
- FDA Inspection 1181069 - 2022-10-06
- FDA Inspection 1096671 - 2019-07-19
- FDA Inspection 1020072 - 2017-07-31
- FDA Inspection 843584 - 2013-08-08
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