American Laboratories Pharma, LLC
Form 483 issued October 3, 2022 · Omaha, Nebraska
- Inspection
- Sep 26 – Oct 3, 2022
- Investigators
- Brent M. Dehaan· Robert J. Ham
- Observations
- 4
- Pages
- 7
- FEI number
- 1920841
In short: On October 3, 2022, FDA issued a Form 483 with 4 observations to American Laboratories Pharma, LLC in Omaha, Nebraska (FEI 1920841) after an inspection that ran Sep 26 – Oct 3, 2022. The investigators were Brent M. Dehaan and Robert J. Ham. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish written procedures to monitor the progress and control the performance of processing steps…
- 02
All specifications, sampling plans, and test procedures should be scientifically sound and appropriate to ensure that…
- 03
Written records of investigations are not established and followed for investigating critical deviations or the failure…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Brent M. Dehaan
4 documents · 2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmAmerican Laboratories Pharma, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Laboratories Pharma, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected American Laboratories Pharma, LLC?
Brent M. Dehaan and Robert J. Ham are named on this Form 483, for the inspection of Sep 26 – Oct 3, 2022. Each investigator has a profile showing what they cite most.
When was American Laboratories Pharma, LLC inspected by FDA?
The inspection ran Sep 26 – Oct 3, 2022, and the Form 483 is dated October 3, 2022.
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.