Eco Lips, Inc.
Form 483 issued July 14, 2023 · Cedar Rapids, Iowa
- Investigator
- Alan M. Barker
- Observations
- 2
- Pages
- 3
- FEI number
- 3004966182
In short: On July 14, 2023, FDA issued a Form 483 with 2 observations to Eco Lips, Inc. in Cedar Rapids, Iowa (FEI 3004966182). The investigator was Alan M. Barker. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production and process…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmEco Lips, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eco Lips, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Eco Lips, Inc.?
Alan M. Barker is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Eco Lips, Inc. inspected by FDA?
This Form 483 is dated July 14, 2023.
How do I get the full Form 483 for Eco Lips, Inc.?
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.