Sunland, Inc.

Form 483 issued September 23, 2010 · Portales, New Mexico

Inspection: Sep 21 – Sep 23, 2010
Investigators: Andrea J. Schmidt· Carla R. Hinz
Observations: 5
Pages: 2
FEI number: 1000117188

In short: On September 23, 2010, FDA issued a Form 483 with 5 observations to Sunland, Inc. in Portales, New Mexico (FEI 1000117188) after an inspection that ran Sep 21 – Sep 23, 2010. The investigators were Andrea J. Schmidt and Carla R. Hinz. Most observations concern food CGMP / preventive controls.

At a glance

5 of 5 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls5

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 110.80
All reasonable precautions are not taken to ensure that production procedures do not contribute…
02
21 CFR 110.35
Effective measures are not being taken to exclude pests from the processing areas and protect against…
03
21 CFR 110.20
The plant is not constructed in such a manner as to allow floors to be…
04
21 CFR 110.10
Failure to wear beard covers…

1 more observation

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

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This inspection in context

The investigator

Andrea J. Schmidt

2 documents · 2010

Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in New Mexico.

The firm

Sunland, Inc. history

All 15 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 110.80

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at Sunland, Inc.?

FDA listed 5 observations on this Form 483, mostly about food CGMP / preventive controls. The opening words of each observation are shown on this page.

Who inspected Sunland, Inc.?

Andrea J. Schmidt and Carla R. Hinz are named on this Form 483, for the inspection of Sep 21 – Sep 23, 2010. Each investigator has a profile showing what they cite most.

When was Sunland, Inc. inspected by FDA?

The inspection ran Sep 21 – Sep 23, 2010, and the Form 483 is dated September 23, 2010.

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

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