FDA Inspection
Engler Engineering Corp.Engler Engineering Corp. – FDA Inspection, Jan 24, 2017
Record Details
This FDA Inspection record concerns Engler Engineering Corp., with an inspection on January 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · d3c80705-e116-4a23-980c-aaa55c714590
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1001775
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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 |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2010 | 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 879038 - 2014-05-07
- FDA Inspection 678108 - 2010-08-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.