Company
United StatesEngler Engineering Corp., Hialeah, FL – FDA Inspections
Inspection records and compliance data for Engler Engineering Corp. in Hialeah, Florida. 5 FDA inspections on record, 1 Form 483, last inspected November 08, 2022.
Company Profile
This profile covers Engler Engineering Corp. based in Hialeah, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected August 25, 2010. Last inspected November 8, 2022.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1187509 |
| January 8, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1118243 |
| January 24, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1001775 |
| May 7, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 879038 |
| August 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678108 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Engler Engineering Corp.
FEI Number
1036336
Address
1099 E 47th St, Hialeah, Florida 33013, United States
Country
United States
ID: 5362c608-770a-473d-b9f4-be56ef7c9f9f