Waterland Laboratories
⚠️ High Risk
FEI: 3003286992 • Lelystad, Flevoland • NETHERLANDS
FEI
FEI Number
3003286992
📍
Location
Lelystad, Flevoland
🇳🇱
Country
NETHERLANDS🏢
Address
Zuiveringweg 40, , Lelystad, Flevoland, Netherlands
High Risk
FDA Import Risk Assessment
63.1
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
60
Total Refusals
2
Unique Violations
3/23/2017
Latest Refusal
3/21/2017
Earliest Refusal
Score Breakdown
Violation Severity
83.2×40%
Refusal Volume
66.1×30%
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
© ImportRefusal.com Original Analysis
Violation Summary
7559×
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).
11812×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2017 | 61KCA46SCOPOLAMINE HYDROBROMIDE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GCA50SULFADOXINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ICA10ERYTHROMYCIN (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61HCA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63HCA01BISACODYL (CATHARTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61HCK99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 62LCA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56ICA10ERYTHROMYCIN (MACROLIDES) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61GCA50SULFADOXINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 64LCA50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61HCK99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61GCA50SULFADOXINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56GCA20GRISEOFULVIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Waterland Laboratories's FDA import refusal history?
Waterland Laboratories (FEI: 3003286992) has 60 FDA import refusal record(s) in our database, spanning from 3/21/2017 to 3/23/2017.
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. Waterland Laboratories's FEI number is 3003286992.
What types of violations has Waterland Laboratories received?
Waterland Laboratories has been cited for 2 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 Waterland Laboratories come from?
All FDA import refusal data for Waterland Laboratories 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.