Lachifarma S.r.l.
⚠️ Moderate Risk
FEI: 3006213660 • Zollino (LE) • ITALY
FEI Number
3006213660
Location
Zollino (LE)
Country
ITALYAddress
Zona Ind.le, , Zollino (LE), , Italy
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2015 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Baltimore District Office (BLT-DO) | |
| 2/27/2014 | 64LBJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 12/9/2011 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/15/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/25/2010 | 64LBO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 9/2/2009 | 64LCJ99GLUCOCORTICOID N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/5/2004 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lachifarma S.r.l.'s FDA import refusal history?
Lachifarma S.r.l. (FEI: 3006213660) has 9 FDA import refusal record(s) in our database, spanning from 8/5/2004 to 1/6/2015.
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. Lachifarma S.r.l.'s FEI number is 3006213660.
What types of violations has Lachifarma S.r.l. received?
Lachifarma S.r.l. has been cited for 7 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 Lachifarma S.r.l. come from?
All FDA import refusal data for Lachifarma S.r.l. 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.