Eco Lips, Inc.
Form 483 issued March 24, 2022 · Cedar Rapids, Iowa
- Investigators
- Michael C. Zubelewicz· Torrey M. Ward
- Observations
- 6
- Pages
- 6
- FEI number
- 3004966182
In short: On March 24, 2022, FDA issued a Form 483 with 6 observations to Eco Lips, Inc. in Cedar Rapids, Iowa (FEI 3004966182). The investigators were Michael C. Zubelewicz and Torrey M. Ward. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
An adequate number of batches of each drug product are not tested to determine…
- 02
There is no written testing program designed to assess the stability…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Michael C. Zubelewicz
3 documents · 2022–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.166(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eco Lips, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Eco Lips, Inc.?
Michael C. Zubelewicz and Torrey M. Ward are 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 March 24, 2022.
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.