ALK-Abello, Inc.
Form 483 issued February 25, 2014 · Port Washington, New York
- Inspection
- Feb 11, 2014
- Investigator
- Susan M. Jackson
- Observations
- 7
- Pages
- 3
- FEI number
- 2431784
In short: On February 25, 2014, FDA issued a Form 483 with 7 observations to ALK-Abello, Inc. in Port Washington, New York (FEI 2431784) after an inspection that ran Feb 11, 2014. The investigator was Susan M. Jackson. Most observations concern production and biologics CGMP; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
5 of 7 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Product is not manufactured as described…
- 02
Procedures designed to prevent microbiological contamination of…
- 03
The written procedure for special mix manufacturing, SOP 16150 ~3.0 The Manufacturing of Made to Order…
- 04
The manufacturing procedure for the use of Ca (b)…
This inspection in context
Susan M. Jackson
13 documents · 2012–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmALK-Abello, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ALK-Abello, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, biologics CGMP and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ALK-Abello, Inc.?
Susan M. Jackson is named on this Form 483, for the inspection of Feb 11, 2014. Each investigator has a profile showing what they cite most.
When was ALK-Abello, Inc. inspected by FDA?
The inspection ran Feb 11, 2014, and the Form 483 is dated February 25, 2014.
How do I get the full Form 483 for ALK-Abello, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.