American Laboratories Pharma, LLC
Form 483 issued May 3, 2024 · Omaha, Nebraska
- Inspection
- Apr 29 – May 3, 2024
- Observations
- 2
- Pages
- 47
- FEI number
- 1920841
In short: On May 3, 2024, FDA issued a Form 483 with 2 observations to American Laboratories Pharma, LLC in Omaha, Nebraska (FEI 1920841) after an inspection that ran Apr 29 – May 3, 2024. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory testing and investigation procedures should be scientifically sound and appropriate to ensure that intermediates and…
- 02
Investigations into critical deviations or the failure of a batch of API to…
This inspection in context
Questions about this 483
What did FDA find at American Laboratories Pharma, LLC?
FDA listed 2 observations 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 American Laboratories Pharma, LLC inspected by FDA?
The inspection ran Apr 29 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for American Laboratories Pharma, LLC?
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.