Batist S.R.O.
⚠️ Moderate Risk
FEI: 3008447410 • Cerveny Kostele • CZECH REPUBLIC
FEI Number
3008447410
Location
Cerveny Kostele
Country
CZECH REPUBLICAddress
Nerudova 744, , Cerveny Kostele, , Czech Republic
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
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 |
|---|---|---|---|
| 9/9/2011 | 85HHDPAD, MENSTRUAL, UNSCENTED | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 79EFQSPONGE, GAUZE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 79KKXDRAPE, SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80MMPCOVER, BARRIER, PROTECTIVE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80FMFSYRINGE, PISTON | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 80KMEBEDDING, DISPOSABLE, MEDICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 79FWZACCESSORIES, OPERATING-ROOM, TABLE (KIT) | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Batist S.R.O.'s FDA import refusal history?
Batist S.R.O. (FEI: 3008447410) has 20 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.
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. Batist S.R.O.'s FEI number is 3008447410.
What types of violations has Batist S.R.O. received?
Batist S.R.O. has been cited for 1 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 Batist S.R.O. come from?
All FDA import refusal data for Batist S.R.O. 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.