Trimed Inc
Form 483 issued March 18, 2016 · Santa Clarita, California
- Inspection
- Mar 7 – Mar 18, 2016
- Investigator
- Janet Pulver
- Observations
- 11
- Pages
- 12
- FEI number
- 3001236812
In short: On March 18, 2016, FDA issued a Form 483 with 11 observations to Trimed Inc in Santa Clarita, California (FEI 3001236812) after an inspection that ran Mar 7 – Mar 18, 2016. The investigator was Janet Pulver. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and production & process controls account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device , labeling and packaging to meet any of…
- 04
Risk analysis is…
- 05
Written MDR procedures have…
- 06
Procedures for product handling have…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmTrimed Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trimed Inc?
FDA listed 11 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Trimed Inc?
Janet Pulver is named on this Form 483, for the inspection of Mar 7 – Mar 18, 2016. Each investigator has a profile showing what they cite most.
When was Trimed Inc inspected by FDA?
The inspection ran Mar 7 – Mar 18, 2016, and the Form 483 is dated March 18, 2016.
How do I get the full Form 483 for Trimed Inc?
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.