AML Riverside, Llc
Form 483 issued April 3, 2019 · Fort Dodge, Iowa
- Inspection
- Mar 25 – Apr 3, 2019
- Investigators
- Michele L. Obert· Wayne D. McGrath
- Observations
- 2
- Pages
- 4
- FEI number
- 1931411
In short: On April 3, 2019, FDA issued a Form 483 with 2 observations to AML Riverside, Llc in Fort Dodge, Iowa (FEI 1931411) after an inspection that ran Mar 25 – Apr 3, 2019. The investigators were Michele L. Obert and Wayne D. McGrath. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Packaging & labeling and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.125(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Strict control is not exercised over labeling issued for use in…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Michele L. Obert
6 documents · 2012–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmAML Riverside, Llc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.125(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AML Riverside, Llc?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected AML Riverside, Llc?
Michele L. Obert and Wayne D. McGrath are named on this Form 483, for the inspection of Mar 25 – Apr 3, 2019. Each investigator has a profile showing what they cite most.
When was AML Riverside, Llc inspected by FDA?
The inspection ran Mar 25 – Apr 3, 2019, and the Form 483 is dated April 3, 2019.
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.