LLOYD, Inc. of Iowa
Form 483 issued February 2, 2018 · Shenandoah, Iowa
- Observations
- 4
- Pages
- 4
- FEI number
- 1911196
In short: On February 2, 2018, FDA issued a Form 483 with 4 observations to LLOYD, Inc. of Iowa in Shenandoah, Iowa (FEI 1911196). Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls 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
There are not separate or defined areas or such other control systems for the firm's operations…
- 02
There are inadequate exhaust systems or other systems to control contaminants in area where air…
- 03
Laboratory controls do not include establishment of scientifically sound and appropriate specifications and test procedures designed…
- 0421 CFR 514.8
Changes in the quantitative formulation of the drug, including in the specification provided in the approved…
This inspection in context
Questions about this 483
What did FDA find at LLOYD, Inc. of Iowa?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was LLOYD, Inc. of Iowa inspected by FDA?
This Form 483 is dated February 2, 2018.
How do I get the full Form 483 for LLOYD, Inc. of Iowa?
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.