Company
United StatesMTI Precision Products LLC., Coatesville, PA – FDA Inspections
Inspection records and compliance data for MTI Precision Products LLC. in Coatesville, Pennsylvania. 5 FDA inspections on record (3 OAI), 1 Form 483, 1 warning letter, last inspected March 10, 2023.
Company Profile
This profile covers MTI Precision Products LLC. based in Coatesville, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 3
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected April 30, 2014. Last inspected March 10, 2023.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
- Design changes - Lack of or Inadequate Procedures2 inspections
- Documented evaluation2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1201688 |
| March 16, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1005671 |
| September 7, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 985380 |
| November 6, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 901704 |
| April 30, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 875249 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MTI Precision Products LLC.
FEI Number
2246821
Address
131 Birch St, Coatesville, Pennsylvania 19320, United States
Country
United States
ID: a582d667-bc3c-45d4-b1de-4fb3a2c2a655