FDA Inspection
Pretzelhaus BakeryPretzelhaus Bakery – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Pretzelhaus Bakery, with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ea352889-8e05-4ffc-a10a-f871354acb27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180(b)Retention period
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Pretzelhaus Bakery
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2023 | Not classified | Baltimore District Office | |
| May 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 6, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Pretzelhaus Bakery
- FDA Inspection 1204666 - 2023-04-19
- FDA Inspection 882155 - 2014-05-29
- FDA Inspection 797571 - 2012-09-06
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