Company
United StatesALK-Abello, Inc., Plainville, CT – FDA Inspections
Inspection records and compliance data for ALK-Abello, Inc. in Plainville, Connecticut. 10 FDA inspections on record (3 OAI), 3 Form 483s, last inspected June 13, 2025.
Company Profile
This profile covers ALK-Abello, Inc. based in Plainville, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 3
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected August 6, 2009. Last inspected June 13, 2025.
Most cited issue areas
- Environmental Monitoring System4 inspections
- Investigations of discrepancies, failures4 inspections
- Procedures for sterile drug products4 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1272585 |
| October 21, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1181903 |
| May 3, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1141073 |
| March 1, 2019 | Not classified | Human Drugs · New Drug Evaluation | 1080880 |
| November 29, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1073636 |
| September 19, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1025749 |
| August 26, 2014 | VAI | Human Drugs · Drug Quality Assurance | 892618 |
| December 19, 2012 | VAI | Human Drugs · Drug Quality Assurance | 813064 |
| May 18, 2012 | VAI | Human Drugs · Drug Quality Assurance | 781640 |
| August 6, 2009 | NAI | Human Drugs · Drug Quality Assurance | 604459 |
FDA documents
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Company Information
Name
ALK-Abello, Inc.
FEI Number
3006900385
Address
10 Farmington Valley Dr Ste 106, Plainville, Connecticut 06062, United States
Country
United States
ID: b626f86d-b379-45aa-96d2-0661e9d1c981