ALK-Abello, Inc.
FDA inspection history in Port Washington, New York, 2014 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Port Washington, New York.
- 2014The longest 483 on file: 7 observations over 3 pages at Port Washington, New York.
- 2023One Form 483, at Port Washington, New York.
Cited most
Across all ALK-Abello observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers1
The complete ALK-Abello file.
All 2 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
Port Washington, New York
Two Form 483s · 2014 to 2023 · 8 observations
Latest: Form 483, Oct 17, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-17 | 483 Form 483 | Port Washington, New York | 1 | $99 |
| 2014-02-25 | 483 Form 483 | Port Washington, New York | 7 | $99 |
Investigators on these documents
FEI number 2431784 · most recent document Oct 17, 2023
About ALK-Abello, Inc.
How many FDA Form 483s has ALK-Abello, Inc. received?
FDA Intel has 2 Form 483s on file for ALK-Abello, Inc.; the most recent is dated Oct 17, 2023.
When was ALK-Abello, Inc. last inspected by FDA?
The most recent FDA inspection document on file for ALK-Abello, Inc. is a Form 483 dated Oct 17, 2023, for the site in Port Washington, New York.
What did FDA cite at ALK-Abello, Inc.?
The regulations cited most in the observations on file for ALK-Abello, Inc. are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.