Trilliant Surgical Ltd
Form 483 issued June 27, 2016 · Houston, Texas
- Inspection
- Feb 16 – Jun 27, 2016
- Investigator
- Ellen J. Tave
- Observations
- 9
- Pages
- 7
- FEI number
- 3007420745
In short: On June 27, 2016, FDA issued a Form 483 with 9 observations to Trilliant Surgical Ltd in Houston, Texas (FEI 3007420745) after an inspection that ran Feb 16 – Jun 27, 2016. The investigator was Ellen J. Tave. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and design controls account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 03
Procedures have not been established to control product that does not…
- 04
Procedures for acceptance activities have…
This inspection in context
Ellen J. Tave
8 documents · 2015–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmTrilliant Surgical Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trilliant Surgical Ltd?
FDA listed 9 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Trilliant Surgical Ltd?
Ellen J. Tave is named on this Form 483, for the inspection of Feb 16 – Jun 27, 2016. Each investigator has a profile showing what they cite most.
When was Trilliant Surgical Ltd inspected by FDA?
The inspection ran Feb 16 – Jun 27, 2016, and the Form 483 is dated June 27, 2016.
How do I get the full Form 483 for Trilliant Surgical Ltd?
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.