Alkermes, Inc.
FDA inspection history across 2 sites, 2019 to 2023
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Form 483
- Close-out
2019: one close-out letter; 2020: one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Two close-out letters, at Waltham, Massachusetts.
- 2023One Form 483, at Wilmington, Ohio.
Cited most
Across all Alkermes observations on file
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Alkermes file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Waltham, Massachusetts
Two close-out letters · 2019 to 2020
Latest: Close-out, Sep 9, 2020 →Wilmington, Ohio
One Form 483 · 2023 · 7 observations
Latest: Form 483, Oct 19, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-19 | 483 Form 483 | Wilmington, Ohio | 7 | $99 |
| 2020-09-09 | Close-out Close-out letter | Waltham, Massachusetts | — | $99 |
| 2019-12-02 | Close-out Close-out letter | Waltham, Massachusetts | — | $99 |
Investigators on these documents
FEI number 1000142940 · most recent document Oct 19, 2023
About Alkermes, Inc.
How many FDA Form 483s has Alkermes, Inc. received?
FDA Intel has 1 Form 483 on file for Alkermes, Inc.; the most recent is dated Oct 19, 2023.
When was Alkermes, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Alkermes, Inc. is a Form 483 dated Oct 19, 2023, for the site in Wilmington, Ohio.
What did FDA cite at Alkermes, Inc.?
The regulations cited most in the observations on file for Alkermes, Inc. are 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.