Wexler Surgical, Inc
Form 483 issued March 20, 2015 · Houston, Texas
- Inspection
- Feb 26 – Mar 20, 2015
- Investigator
- Ellen J. Tave
- Observations
- 6
- Pages
- 4
- FEI number
- 1000160162
In short: On March 20, 2015, FDA issued a Form 483 with 6 observations to Wexler Surgical, Inc in Houston, Texas (FEI 1000160162) after an inspection that ran Feb 26 – Mar 20, 2015. The investigator was Ellen J. Tave. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
A device master record has…
- 03
Procedures for design validation have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit 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 firmWexler Surgical, Inc history
The site's inspection history, in date order.
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 Wexler Surgical, Inc?
FDA listed 6 observations on this Form 483, mostly about design controls, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Wexler Surgical, Inc?
Ellen J. Tave is named on this Form 483, for the inspection of Feb 26 – Mar 20, 2015. Each investigator has a profile showing what they cite most.
When was Wexler Surgical, Inc inspected by FDA?
The inspection ran Feb 26 – Mar 20, 2015, and the Form 483 is dated March 20, 2015.
How do I get the full Form 483 for Wexler Surgical, 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.