American Laboratories Pharma, LLC
Form 483 issued December 1, 2017 · Omaha, Nebraska
- Inspection
- Nov 27 – Dec 1, 2017
- Observations
- 4
- Pages
- 1
- FEI number
- 1920841
In short: On December 1, 2017, FDA issued a Form 483 with 4 observations to American Laboratories Pharma, LLC in Omaha, Nebraska (FEI 1920841) after an inspection that ran Nov 27 – Dec 1, 2017. Most observations concern quality system and production.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your “Verification of Thyroid Drying Consistency — Batches up to (b)(4) Pounds” for the (b)(4) in…
- 02
Your procedure 24-0006 “Returned Finished Product Procedures — Receiving & Control” is deficient in that it…
- 03
Your investigation for Complaint-787 for Staphylococcus aureus in Lot 02770125 Thyroid Full…
- 04
Procedure 24-0008 “Deviations / Discrepancy Investigations” is deficient in that it allows you to perform a…
This inspection in context
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 and production. The opening words of each observation are shown on this page.
When was American Laboratories Pharma, LLC inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2017, and the Form 483 is dated December 1, 2017.
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.