FDA Inspection
Millar, Inc.Millar, Inc. – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Millar, Inc., with an inspection on February 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Millar, Inc.
- Inspection Date
- February 2, 2012
- Product Type
- Devices
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ID · cc9cc7d7-cf3f-40f7-b537-7c22b682291c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 766250
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Millar, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2025 | NAI | Dallas District Office | Postmarket Assurance: Medical Devices |
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Millar, Inc.
- FDA Inspection 1274368 - 2025-07-01
- FDA Inspection 1020984 - 2017-02-23
- FDA Inspection 830052 - 2013-04-19
- FDA Inspection 720852 - 2011-04-21
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