OLIVE BRANCH NATURAL BODY CARE LLC

Form 483 issued April 2, 2019 · Seattle, Washington

Inspection
Mar 26 – Apr 2, 2019
Investigator
Andrew K. Haack
Observations
2
Pages
5

In short: On April 2, 2019, FDA issued a Form 483 with 2 observations to OLIVE BRANCH NATURAL BODY CARE LLC in Seattle, Washington after an inspection that ran Mar 26 – Apr 2, 2019. The investigator was Andrew K. Haack. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

Quality system and production account for 2 of 2 observations.

Quality system1
Production1

Most cited: 21 CFR 211.22 (1×) · 211.188 (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

    There is no quality…

  2. 02

    Batch production and control records do not include complete information relating to the production and…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at OLIVE BRANCH NATURAL BODY CARE LLC?

FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

Who inspected OLIVE BRANCH NATURAL BODY CARE LLC?

Andrew K. Haack is named on this Form 483, for the inspection of Mar 26 – Apr 2, 2019. Each investigator has a profile showing what they cite most.

When was OLIVE BRANCH NATURAL BODY CARE LLC inspected by FDA?

The inspection ran Mar 26 – Apr 2, 2019, and the Form 483 is dated April 2, 2019.

How do I get the full Form 483 for OLIVE BRANCH NATURAL BODY CARE LLC?

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