FDA Intel

Eco Lips, Inc.

Form 483 issued March 31, 2021 · Cedar Rapids, Iowa

Investigators
Carl A. Huffman· Torrey M. Ward
Observations
4
Pages
4
FEI number
3004966182

In short: On March 31, 2021, FDA issued a Form 483 with 4 observations to Eco Lips, Inc. in Cedar Rapids, Iowa (FEI 3004966182). The investigators were Carl A. Huffman and Torrey M. Ward. Most observations concern packaging & labeling and quality system.

At a glance

Observations span 4 systems, led by packaging & labeling.

Packaging & labeling1
Quality system1
Production1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.137(a)

    Drug products do not bear an expiration date determined by appropriate stability data to assure they…

  2. 02
    21 CFR 211.180(e)(2)

    The procedures for the annual quality standards record evaluation are deficient in that they do not…

  3. 03
    21 CFR 211.100(a)

    There are no written procedures for production and process controls designed to assure that the drug…

  4. 04
    21 CFR 211.170(a)

    The reserve sample of active ingredient does not consist of at least twice the quantity necessary…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Carl A. Huffman

11 documents · 2015–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.

The firm

Eco Lips, Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.137(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Eco Lips, Inc.?

FDA listed 4 observations on this Form 483, mostly about packaging & labeling, quality system and production. The opening words of each observation are shown on this page.

Who inspected Eco Lips, Inc.?

Carl A. Huffman 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 31, 2021.

How do I get the full Form 483 for Eco Lips, Inc.?

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