Prollenium Medical Technologies Inc.
⚠️ High Risk
FEI: 3004423487 • Aurora, Ontario • CANADA
FEI Number
3004423487
Location
Aurora, Ontario
Country
CANADAAddress
138 Industrial Pky N, , Aurora, Ontario, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/17/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/14/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/2/2022 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 5/2/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 12/19/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/13/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/1/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 2/5/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 2/14/2020 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/15/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/10/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/8/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/3/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/3/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/3/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/3/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 3/28/2019 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/27/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 3/21/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 3/19/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 3/19/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 5/23/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 1/11/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/9/2007 | 75LZXACID, SODIUM HYALURONIC | Detroit District Office (DET-DO) | |
| 9/15/2005 | 79GDFGUIDE, NEEDLE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/14/2004 | 66VIK99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 9/14/2004 | 65QCK37AMINOPHYLLINE (RELAXANT) | Detroit District Office (DET-DO) | |
| 9/14/2004 | 66VIK99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 9/14/2004 | 60QCK46PROCAINE HCL (ANESTHETIC) | Detroit District Office (DET-DO) | |
| 4/12/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 60QAP46PROCAINE HCL (ANESTHETIC) | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 66BAY05CAFFEINE (STIMULANT) | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/12/2004 | 54AGK13VITAMIN C (ASCORBIC ACID) | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 60QAP46PROCAINE HCL (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 60QCL46PROCAINE HCL (ANESTHETIC) | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 62BCL99ANTI-HYPERLIPIDEMIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 66JCL99THYROID HORMONE N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 60QIY46PROCAINE HCL (ANESTHETIC) | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 66SCL99VASODILATOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 66BIY05CAFFEINE (STIMULANT) | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 66BAL05CAFFEINE (STIMULANT) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Prollenium Medical Technologies Inc.'s FDA import refusal history?
Prollenium Medical Technologies Inc. (FEI: 3004423487) has 73 FDA import refusal record(s) in our database, spanning from 2/4/2004 to 5/3/2024.
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. Prollenium Medical Technologies Inc.'s FEI number is 3004423487.
What types of violations has Prollenium Medical Technologies Inc. received?
Prollenium Medical Technologies Inc. has been cited for 14 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 Prollenium Medical Technologies Inc. come from?
All FDA import refusal data for Prollenium Medical Technologies Inc. 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.