Pharma Vital Sa
⚠️ Moderate Risk
FEI: 3004604370 • Colon • PANAMA
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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.
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 2/7/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 2/7/2006 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 2/7/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 335LACKS N/C | New Orleans District Office (NOL-DO) |
| 2/7/2006 | 89LZXACID, SODIUM HYALURONIC, INTRA-ARTICULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 2/7/2006 | 60QBL99ANESTHETIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/14/2004 | 75LZXACID, SODIUM HYALURONIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/14/2004 | 75LZXACID, SODIUM HYALURONIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/4/2004 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | New Orleans District Office (NOL-DO) | |
| 8/31/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharma Vital Sa's FDA import refusal history?
Pharma Vital Sa (FEI: 3004604370) has 10 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 2/7/2006.
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. Pharma Vital Sa's FEI number is 3004604370.
What types of violations has Pharma Vital Sa received?
Pharma Vital Sa has been cited for 8 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 Pharma Vital Sa come from?
All FDA import refusal data for Pharma Vital Sa 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.