AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care

Form 483 issued December 6, 2018 · Lafayette, Louisiana

Observations
4
Pages
2
FEI number
2315837

In short: On December 6, 2018, FDA issued a Form 483 with 4 observations to AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care in Lafayette, Louisiana (FEI 2315837). Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).

At a glance

Observations span 1 system, led by capa.

CAPA1
Other3

Most cited: 21 CFR 820.100 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Tite Cer) ample Fee. Cemwel tof LITICO“IT cvrn ner be…

  2. 02

    Observation 2: scanned text, readable in the full document.

  3. 03

    Observation 3: scanned text, readable in the full document.

  4. 04

    Observation 4: scanned text, readable in the full document.

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Questions about this 483

What did FDA find at AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care?

FDA listed 4 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.

When was AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care inspected by FDA?

This Form 483 is dated December 6, 2018.

How do I get the full Form 483 for AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care?

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