AML Riverside, Llc
Form 483 issued August 18, 2023 · Fort Dodge, Iowa
- Observations
- 3
- Pages
- 3
- FEI number
- 1931411
In short: On August 18, 2023, FDA issued a Form 483 with 3 observations to AML Riverside, Llc in Fort Dodge, Iowa (FEI 1931411). Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
All processing lines and major equipment used during the production of a batch of drug product…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Questions about this 483
What did FDA find at AML Riverside, Llc?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
When was AML Riverside, Llc inspected by FDA?
This Form 483 is dated August 18, 2023.
How do I get the full Form 483 for AML Riverside, 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.