Smith & Nephew Wound Management
FDA inspection history in Fort Worth, Texas, 2021 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22Two Form 483s, at Fort Worth, Texas.
- 2021The longest 483 on file: 7 observations over 6 pages at Fort Worth, Texas.
Cited most
Across all Smith & Nephew Wound Management observations on file
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.192Production record review1
The complete Smith & Nephew Wound Management file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fort Worth, Texas
Two Form 483s · 2021 to 2022 · 11 observations
Latest: Form 483, Sep 30, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-30 | 483 Form 483 | Fort Worth, Texas | 4 | $99 |
| 2021-07-20 | 483 Form 483 | Fort Worth, Texas | 7 | $99 |
Investigators on these documents
Eric L. Dong (1)Lane V. Christensen (1)Laurimer Kuilan-Torres (1)
FEI number 3011034132 · most recent document Sep 30, 2022
About Smith & Nephew Wound Management
How many FDA Form 483s has Smith & Nephew Wound Management received?
FDA Intel has 2 Form 483s on file for Smith & Nephew Wound Management; the most recent is dated Sep 30, 2022.
When was Smith & Nephew Wound Management last inspected by FDA?
The most recent FDA inspection document on file for Smith & Nephew Wound Management is a Form 483 dated Sep 30, 2022, for the site in Fort Worth, Texas.
What did FDA cite at Smith & Nephew Wound Management?
The regulations cited most in the observations on file for Smith & Nephew Wound Management are 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.