Eco Lips, Inc.
Form 483 issued September 25, 2019 · Cedar Rapids, Iowa
- Inspection
- Sep 23 – Sep 25, 2019
- Investigator
- Ross J. Grigsby
- Observations
- 7
- Pages
- 4
- FEI number
- 3004966182
In short: On September 25, 2019, FDA issued a Form 483 with 7 observations to Eco Lips, Inc. in Cedar Rapids, Iowa (FEI 3004966182) after an inspection that ran Sep 23 – Sep 25, 2019. The investigator was Ross J. Grigsby. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Complaint records are deficient in that they do not include the…
This inspection in context
Ross J. Grigsby
8 documents · 2017–2021
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eco Lips, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Eco Lips, Inc.?
Ross J. Grigsby is named on this Form 483, for the inspection of Sep 23 – Sep 25, 2019. Each investigator has a profile showing what they cite most.
When was Eco Lips, Inc. inspected by FDA?
The inspection ran Sep 23 – Sep 25, 2019, and the Form 483 is dated September 25, 2019.
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.