Smith & Nephew Wound Management
Form 483 issued September 30, 2022 · Fort Worth, Texas
- Inspection
- Sep 26 – Sep 30, 2022
- Investigators
- Lane V. Christensen· Laurimer Kuilan-Torres
- Observations
- 4
- Pages
- 4
- FEI number
- 3011034132
In short: On September 30, 2022, FDA issued a Form 483 with 4 observations to Smith & Nephew Wound Management in Fort Worth, Texas (FEI 3011034132) after an inspection that ran Sep 26 – Sep 30, 2022. The investigators were Lane V. Christensen and Laurimer Kuilan-Torres. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.166 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Stability study testing program…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Failure to provide facilities and equipment that…
This inspection in context
Lane V. Christensen
2 documents · 2022–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
The firmSmith & Nephew Wound Management history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Smith & Nephew Wound Management?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Smith & Nephew Wound Management?
Lane V. Christensen and Laurimer Kuilan-Torres are named on this Form 483, for the inspection of Sep 26 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was Smith & Nephew Wound Management inspected by FDA?
The inspection ran Sep 26 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
How do I get the full Form 483 for Smith & Nephew Wound Management?
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.