Company
United StatesPromeko, Inc., West New York, NJ – FDA Inspections
Inspection records and compliance data for Promeko, Inc. in West New York, New Jersey. 4 FDA inspections on record, last inspected November 05, 2019.
Company Profile
This profile covers Promeko, Inc. based in West New York, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 30, 2011. Last inspected November 5, 2019.
Most cited issue areas
- Identity Testing of Each Component1 inspection
- Lack of quality control unit1 inspection
- Procedures to be written and followed1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 5, 2019 | NAI | Foods & Cosmetics · Colors and Cosmetics Technology | 1109716 |
| October 17, 2016 | NAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 995397 |
| November 21, 2013 | VAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 858056 |
| August 30, 2011 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 739400 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Promeko, Inc.
FEI Number
2242975
Address
543 59th St, West New York, New Jersey 07093, United States
Country
United States
ID: a5e1fcc6-7624-4716-b7c1-e296fdbd22e4