Company
United StatesPublic company, NASDAQ: ALKSAlkermes, Inc. (NASDAQ: ALKS), Waltham, MA – FDA Inspections
Inspection records and compliance data for Alkermes, Inc. in Waltham, Massachusetts. 4 FDA inspections on record, 1 warning letter, last inspected May 28, 2015. Publicly traded as NASDAQ: ALKS.
Company Profile
This profile covers Alkermes, Inc. based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 1
First inspected September 29, 2009. Last inspected May 28, 2015.
Most cited issue areas
- Late submission of 15-day report1 inspection
- Submission of report follow-up1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 28, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 933726 |
| December 12, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 859795 |
| June 15, 2012 | NAI | Human Drugs · Postmarket Surv. and Epidemiology | 790639 |
| September 29, 2009 | VAI | Human Drugs · Bioresearch Monitoring | 615049 |
FDA documents
Warning Letters (1)
Other FDA documents (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alkermes, Inc.
Stock ticker
ALKS
Exchange
NASDAQ
Share price
$46.98
Market cap
$7.9B
Price as of
November 13, 2026
FEI Number
1000513229
Address
852 Winter St, Waltham, Massachusetts 02451, United States
Country
United States
ID: 2a5efa83-7984-4306-9df7-b25ba2decb67