FDA Inspection
Almark Tool & Manufacturing Company, Inc.Almark Tool & Manufacturing Company, Inc. – FDA Inspection, Feb 7, 2023
Record Details
This FDA Inspection record concerns Almark Tool & Manufacturing Company, Inc., with an inspection on February 7, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89851e88-73bb-4ef0-b180-39604bb07a6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196549
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Showing 10 of 12 citations.
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Other FDA inspections of Almark Tool & Manufacturing Company, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Almark Tool & Manufacturing Company, Inc.
- FDA Inspection 1041346 - 2018-01-24
- FDA Inspection 907128 - 2014-12-15
- FDA Inspection 832436 - 2013-05-20
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