FDA Inspection
Engler Engineering Corp.Engler Engineering Corp. – FDA Inspection, Aug 25, 2010
Record Details
This FDA Inspection record concerns Engler Engineering Corp., with an inspection on August 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Engler Engineering Corp.
- Inspection Date
- August 25, 2010
- Product Type
- Devices
View Company Profile
ID · d1c46286-b93e-4e7d-acdd-239db1f7fb1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Engler Engineering Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Engler Engineering Corp.
- FDA Inspection 1187509 - 2022-11-08
- FDA Inspection 1118243 - 2020-01-08
- FDA Inspection 1001775 - 2017-01-24
- FDA Inspection 879038 - 2014-05-07
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