Pam Pharmaceutical

⚠️ Moderate Risk

FEI: 3009614077 • Surendranagar363035 • INDIA

FEI

FEI Number

3009614077

📍

Location

Surendranagar363035

🇮🇳

Country

INDIA

🏢

Address

G. I. D. C. Phase Iv Plot No. 1924/ A, , Wadhwan City Gujrat, Surendranagar363035, , India

Moderate Risk

FDA Import Risk Assessment

42.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/14/2012

Latest Refusal

8/14/2012

Earliest Refusal

Score Breakdown

Violation Severity

71.4×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

754×

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).

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

33201×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

Date	Product	Violations	Division
8/14/2012	33EGE99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	260FALSE 3320TRANSFAT 482NUTRIT LBL	New York District Office (NYK-DO)
8/14/2012	66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
8/14/2012	66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
8/14/2012	66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
8/14/2012	66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Pam Pharmaceutical's FDA import refusal history?

Pam Pharmaceutical (FEI: 3009614077) has 5 FDA import refusal record(s) in our database, spanning from 8/14/2012 to 8/14/2012.

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. Pam Pharmaceutical's FEI number is 3009614077.

What types of violations has Pam Pharmaceutical received?

Pam Pharmaceutical 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 Pam Pharmaceutical come from?

All FDA import refusal data for Pam Pharmaceutical 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.