Sunland, Inc.

Form 483 issued October 25, 2007 · Portales, New Mexico

Inspection
Oct 23 – Oct 25, 2007
Investigator
Charles D. Brown
Observations
6
Pages
4
FEI number
1000117188

In short: On October 25, 2007, FDA issued a Form 483 with 6 observations to Sunland, Inc. in Portales, New Mexico (FEI 1000117188) after an inspection that ran Oct 23 – Oct 25, 2007. The investigator was Charles D. Brown. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).

At a glance

6 of 6 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls6

Most cited: 21 CFR 110.80 (3×) · 110.35 (2×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Failure to manufacture foods under conditions and controls necessary to minimize the potential for…

  2. 02

    All reasonable precautions are not taken to ensure that production procedures do not contribute…

  3. 03

    Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work…

  4. 04

    Effective measures are not being taken to protect against the contamination of food on…

2 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Sunland, Inc.?

FDA listed 6 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.

Who inspected Sunland, Inc.?

Charles D. Brown is named on this Form 483, for the inspection of Oct 23 – Oct 25, 2007. Each investigator has a profile showing what they cite most.

When was Sunland, Inc. inspected by FDA?

The inspection ran Oct 23 – Oct 25, 2007, and the Form 483 is dated October 25, 2007.

How do I get the full Form 483 for Sunland, 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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