Pharma Vital

⚠️ Moderate Risk

FEI: 3004554313 • Plaza Panama, Provincia de Panama • PANAMA

FEI

FEI Number

3004554313

📍

Location

Plaza Panama, Provincia de Panama

🇵🇦

Country

PANAMA

🏢

Address

Urb Marbella Edif Royal Cenber Pb Local, , Plaza Panama, Provincia de Panama, Panama

Moderate Risk

FDA Import Risk Assessment

39.9

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/6/2004

Latest Refusal

12/6/2004

Earliest Refusal

Score Breakdown

Violation Severity

42.0×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

47411×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4735×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4715×

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.

751×

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).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

3331×

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.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

Date	Product	Violations	Division
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	473LABELING 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	473LABELING 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	473LABELING 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	473LABELING 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	473LABELING 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	60QDK46PROCAINE HCL (ANESTHETIC)	472NO ENGLISH	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	54CEL23L-CARNITINE (PROTEIN)	471CSTIC LBLG 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	54CEL23L-CARNITINE (PROTEIN)	333LACKS FIRM 474COSMETLBLG	Florida District Office (FLA-DO)
12/6/2004	79KGMSILICONE, LIQUID, INJECTABLE	75UNAPPROVED	Florida District Office (FLA-DO)
12/6/2004	66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pharma Vital's FDA import refusal history?

Pharma Vital (FEI: 3004554313) has 14 FDA import refusal record(s) in our database, spanning from 12/6/2004 to 12/6/2004.

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's FEI number is 3004554313.

What types of violations has Pharma Vital received?

Pharma Vital 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 Pharma Vital come from?

All FDA import refusal data for Pharma Vital 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.