ALK-Abello, Inc.
Form 483 issued October 17, 2023 · Port Washington, New York
- Inspection
- Oct 11 – Oct 17, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 2431784
In short: On October 17, 2023, FDA issued a Form 483 with 1 observation to ALK-Abello, Inc. in Port Washington, New York (FEI 2431784) after an inspection that ran Oct 11 – Oct 17, 2023. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Questions about this 483
What did FDA find at ALK-Abello, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was ALK-Abello, Inc. inspected by FDA?
The inspection ran Oct 11 – Oct 17, 2023, and the Form 483 is dated October 17, 2023.
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.