Robbins Instruments, LLC
Form 483 issued May 31, 2024 · Houston, Texas
- Inspection
- Mar 27 – May 31, 2024
- Investigator
- Jocelyn C. Turner
- Observations
- 12
- Pages
- 13
- FEI number
- 2221941
In short: On May 31, 2024, FDA issued a Form 483 with 12 observations to Robbins Instruments, LLC in Houston, Texas (FEI 2221941) after an inspection that ran Mar 27 – May 31, 2024. The investigator was Jocelyn C. Turner. Most observations concern production & process controls and cAPA.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Design output was not reviewed and approved…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jocelyn C. Turner
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmRobbins Instruments, 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Robbins Instruments, LLC?
FDA listed 12 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Robbins Instruments, LLC?
Jocelyn C. Turner is named on this Form 483, for the inspection of Mar 27 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was Robbins Instruments, LLC inspected by FDA?
The inspection ran Mar 27 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for Robbins Instruments, 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.