CIRIMAR LABORATORIES INCORPORATE
⚠️ Moderate Risk
FEI: 3012442528 • Taguig City, National Capital Region • PHILIPPINES
FEI Number
3012442528
Location
Taguig City, National Capital Region
Country
PHILIPPINESAddress
, Metro, , Taguig City, National Capital Region, Philippines
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).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2019 | 55QP41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/2/2016 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/6/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/13/2012 | 55QG41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | New York District Office (NYK-DO) | |
| 7/27/2004 | 60VAL99ANTERIOR PITUITARY SUPPRESSOR N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2004 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CIRIMAR LABORATORIES INCORPORATE's FDA import refusal history?
CIRIMAR LABORATORIES INCORPORATE (FEI: 3012442528) has 6 FDA import refusal record(s) in our database, spanning from 3/17/2004 to 3/14/2019.
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. CIRIMAR LABORATORIES INCORPORATE's FEI number is 3012442528.
What types of violations has CIRIMAR LABORATORIES INCORPORATE received?
CIRIMAR LABORATORIES INCORPORATE 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 CIRIMAR LABORATORIES INCORPORATE come from?
All FDA import refusal data for CIRIMAR LABORATORIES INCORPORATE 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.