Sherwood, Davis & Geck
⚠️ Moderate Risk
FEI: 1924954 • Saint Louis, MO • UNITED STATES
FEI Number
1924954
Location
Saint Louis, MO
Country
UNITED STATESAddress
1915 Olive St, , Saint Louis, MO, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2002 | 80FPKTUBING, FLUID DELIVERY | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80JOLCATHETER AND TIP, SUCTION | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80JOLCATHETER AND TIP, SUCTION | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 79KGZACCESSORIES, CATHETER | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80JOLCATHETER AND TIP, SUCTION | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 76EJISYRINGE, CARTRIDGE | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 73BZACONNECTOR, AIRWAY (EXTENSION) | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 78FEGTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 81GIOTUBE, COLLECTION, CAPILLARY BLOOD | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 73CATCANNULA, NASAL, OXYGEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 79GBPCATHETER, MULTIPLE LUMEN | Chicago District Office (CHI-DO) | |
| 8/13/2002 | 78MSDCATHETER, HEMODIALYSIS, IMPLANTED | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 80FPKTUBING, FLUID DELIVERY | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 80JOLCATHETER AND TIP, SUCTION | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 79KGZACCESSORIES, CATHETER | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 73CATCANNULA, NASAL, OXYGEN | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 79GBPCATHETER, MULTIPLE LUMEN | Chicago District Office (CHI-DO) | |
| 5/11/2002 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Sherwood, Davis & Geck's FDA import refusal history?
Sherwood, Davis & Geck (FEI: 1924954) has 30 FDA import refusal record(s) in our database, spanning from 5/11/2002 to 8/13/2002.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sherwood, Davis & Geck's FEI number is 1924954.
What types of violations has Sherwood, Davis & Geck received?
Sherwood, Davis & Geck has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Sherwood, Davis & Geck come from?
All FDA import refusal data for Sherwood, Davis & Geck is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.