Company
United StatesAlk-abello, Inc., Port Washington, NY – FDA Inspections
Inspection records and compliance data for Alk-abello, Inc. in Port Washington, New York. 8 FDA inspections on record, 5 Form 483s, last inspected September 23, 2026.
Company Profile
This profile covers Alk-abello, Inc. based in Port Washington, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 7
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 5
- Warning letters
- 0
First inspected November 19, 2009. Last inspected September 23, 2026.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Calibration/Inspection/Checking not done1 inspection
- Computer control of master formula records1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2026 | Not classified | Biologics · Vaccines and Allergenic Products | 1323588 |
| October 17, 2023 | VAI | Biologics · Vaccines and Allergenic Products | 1220460 |
| March 9, 2023 | VAI | Biologics · Vaccines and Allergenic Products | 1202393 |
| October 30, 2018 | VAI | Biologics · Vaccines and Allergenic Products | 1070323 |
| December 21, 2016 | VAI | Biologics · Vaccines and Allergenic Products | 1002541 |
| February 25, 2014 | VAI | Biologics · Vaccines and Allergenic Products | 871138 |
| March 21, 2012 | VAI | Biologics · Vaccines and Allergenic Products | 780215 |
| November 19, 2009 | VAI | Biologics · Vaccines and Allergenic Products | 637152 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alk-abello, Inc.
FEI Number
2431784
Address
35 Channel Dr, Port Washington, New York 11050, United States
Country
United States
ID: 88a052a0-f653-45ca-a45e-89003e4e8565