FDA Inspection
Steritec Products Mfg. Co., Inc.Steritec Products Mfg. Co., Inc. – FDA Inspection, Feb 1, 2017
Record Details
This FDA Inspection record concerns Steritec Products Mfg. Co., Inc., with an inspection on February 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3f309654-f751-497f-89bc-b61df02e5aab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000027
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Steritec Products Mfg. Co., Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 2, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Steritec Products Mfg. Co., Inc.
- FDA Inspection 1192098 - 2022-12-01
- FDA Inspection 831157 - 2013-05-01
- FDA Inspection 675641 - 2010-08-12
- FDA Inspection 585881 - 2009-06-02
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