TECSER LABORATORIOS S.A
⚠️ Moderate Risk
FEI: 3006378654 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3006378654
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
CALLE 23B #104B- 43 / 59, , Bogota, Cundinamarca, Colombia
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).
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.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 10/25/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2008 | 62QAJ99ANTI-RHEUMATIC N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/27/2008 | 64XBJ06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/29/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TECSER LABORATORIOS S.A's FDA import refusal history?
TECSER LABORATORIOS S.A (FEI: 3006378654) has 6 FDA import refusal record(s) in our database, spanning from 8/29/2005 to 1/19/2021.
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. TECSER LABORATORIOS S.A's FEI number is 3006378654.
What types of violations has TECSER LABORATORIOS S.A received?
TECSER LABORATORIOS S.A 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 TECSER LABORATORIOS S.A come from?
All FDA import refusal data for TECSER LABORATORIOS S.A 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.