MTI Precision Products LLC
FDA inspection history across 2 sites, 2014 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One warning letter and one Form 483, at Lakewood, New Jersey and Coatesville, Pennsylvania.
Cited most
Across all MTI Precision Products observations on file
- 21 CFR 820.181Device master record1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.25(a)Personnel1
- 21 CFR 820.30(i)Design controls1
- 21 CFR 820.40(a)Document controls1
The complete MTI Precision Products file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Coatesville, Pennsylvania
One Form 483 · 2016 · 8 observations
Latest: Form 483, Sep 7, 2016 →Lakewood, New Jersey
One warning letter · 2014
Latest: Warning letter, Jun 6, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-09-07 | 483 Form 483 | Coatesville, Pennsylvania | 8 | $99 |
| 2014-06-06 | Warning letter Warning letter | Lakewood, New Jersey | — | $99 |
Investigators on these documents
FEI number 2246821 · most recent document Sep 7, 2016
About MTI Precision Products LLC
How many FDA Form 483s has MTI Precision Products LLC received?
FDA Intel has 1 Form 483 on file for MTI Precision Products LLC; the most recent is dated Sep 7, 2016.
When was MTI Precision Products LLC last inspected by FDA?
The most recent FDA inspection document on file for MTI Precision Products LLC is a Form 483 dated Sep 7, 2016, for the site in Coatesville, Pennsylvania.
What did FDA cite at MTI Precision Products LLC?
The regulations cited most in the observations on file for MTI Precision Products LLC are 21 CFR 820.181 (Device master record), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.25(a) (Personnel), 1 time.
Has MTI Precision Products LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for MTI Precision Products LLC; the most recent is dated Jun 6, 2014.