MTI Precision Products LLC
Form 483 issued September 7, 2016 · Coatesville, Pennsylvania
- Inspection
- Aug 15 – Sep 7, 2016
- Investigator
- Edward D. McDonald
- Observations
- 8
- Pages
- 4
- FEI number
- 2246821
In short: On September 7, 2016, FDA issued a Form 483 with 8 observations to MTI Precision Products LLC in Coatesville, Pennsylvania (FEI 2246821) after an inspection that ran Aug 15 – Sep 7, 2016. The investigator was Edward D. McDonald. Most observations concern production & process controls and records & documents.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change…
- 02
Complaint files are not…
- 03
Acceptance activities were not…
- 04
A device master record…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMTI Precision Products LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MTI Precision Products LLC?
FDA listed 8 observations on this Form 483, mostly about production & process controls, records & documents and design controls. The opening words of each observation are shown on this page.
Who inspected MTI Precision Products LLC?
Edward D. McDonald is named on this Form 483, for the inspection of Aug 15 – Sep 7, 2016. Each investigator has a profile showing what they cite most.
When was MTI Precision Products LLC inspected by FDA?
The inspection ran Aug 15 – Sep 7, 2016, and the Form 483 is dated September 7, 2016.
How do I get the full Form 483 for MTI Precision Products LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.