Chirana T. Injecta, A.s.
⚠️ Moderate Risk
FEI: 3008272066 • Stara Tura, Trenciansky • SLOVAKIA
FEI Number
3008272066
Location
Stara Tura, Trenciansky
Country
SLOVAKIAAddress
Nam. Dr. Schweitzera 194, , Stara Tura, Trenciansky, Slovakia
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/10/2019 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/24/2011 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | Cincinnati District Office (CIN-DO) | |
| 5/24/2011 | 80KZHINTRODUCER, SYRINGE NEEDLE | Cincinnati District Office (CIN-DO) | |
| 5/24/2011 | 64MCK10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 5/24/2011 | 64MDZ99GONAD-STIMULATING PRINCIPLE N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Chirana T. Injecta, A.s.'s FDA import refusal history?
Chirana T. Injecta, A.s. (FEI: 3008272066) has 5 FDA import refusal record(s) in our database, spanning from 5/24/2011 to 6/10/2019.
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. Chirana T. Injecta, A.s.'s FEI number is 3008272066.
What types of violations has Chirana T. Injecta, A.s. received?
Chirana T. Injecta, A.s. has been cited for 4 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 Chirana T. Injecta, A.s. come from?
All FDA import refusal data for Chirana T. Injecta, A.s. 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.