Morton Salt Inc

Form 483 issued August 19, 2016 · Grand Saline, Texas

Inspection
Aug 16 – Aug 19, 2016
Investigator
Scott Ballard
Observations
4
Pages
2
FEI number
1610635

In short: On August 19, 2016, FDA issued a Form 483 with 4 observations to Morton Salt Inc in Grand Saline, Texas (FEI 1610635) after an inspection that ran Aug 16 – Aug 19, 2016. The investigator was Scott Ballard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

3 of 4 observations on this 483 concern facilities & equipment.

Facilities & equipment3
Other1

Most cited: 21 CFR 211.67 (2×) · 211.46 (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

    Equipment is not adequately…

  2. 02

    There is no environmental design, control, or monitoring for the…

  3. 03

    Cleaning procedures are not…

  4. 04

    Manufacturing equipment is not…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Morton Salt Inc?

FDA listed 4 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected Morton Salt Inc?

Scott Ballard is named on this Form 483, for the inspection of Aug 16 – Aug 19, 2016. Each investigator has a profile showing what they cite most.

When was Morton Salt Inc inspected by FDA?

The inspection ran Aug 16 – Aug 19, 2016, and the Form 483 is dated August 19, 2016.

How do I get the full Form 483 for Morton Salt 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.

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