Smith & Nephew Wound Management
Form 483 issued July 20, 2021 · Fort Worth, Texas
- Inspection
- Jul 12 – Jul 20, 2021
- Investigator
- Eric L. Dong
- Observations
- 7
- Pages
- 6
- FEI number
- 3011034132
In short: On July 20, 2021, FDA issued a Form 483 with 7 observations to Smith & Nephew Wound Management in Fort Worth, Texas (FEI 3011034132) after an inspection that ran Jul 12 – Jul 20, 2021. The investigator was Eric L. Dong. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
5 of 7 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Record entries documenting your unit operations, including equipment cleaning were not made…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Eric L. Dong
4 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Smith & Nephew Wound Management?
FDA listed 7 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Smith & Nephew Wound Management?
Eric L. Dong is named on this Form 483, for the inspection of Jul 12 – Jul 20, 2021. Each investigator has a profile showing what they cite most.
When was Smith & Nephew Wound Management inspected by FDA?
The inspection ran Jul 12 – Jul 20, 2021, and the Form 483 is dated July 20, 2021.
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.