Sunland, Inc.
Form 483 issued October 16, 2012 · Portales, New Mexico
- Inspection
- Sep 17 – Oct 16, 2012
- Investigators
- Gloria A. Milster· Isabel Y. Espinosa· J. Lahar
- Observations
- 10
- Pages
- 11
- FEI number
- 1000117188
In short: On October 16, 2012, FDA issued a Form 483 with 10 observations to Sunland, Inc. in Portales, New Mexico (FEI 1000117188) after an inspection that ran Sep 17 – Oct 16, 2012. The investigators were Gloria A. Milster, Isabel Y. Espinosa, J. Lahar and L. C. Dion. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
10 of 10 observations on this 483 concern food cgmp / preventive controls.
What FDA observed
Preview: the opening words of each observation- 01
Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth…
- 02
Failure to handle equipment, containers and utensils used to convey, hold, and store food in a…
- 03
Food contact surfaces used for manufacturing low-moisture food were wet…
- 04
The design and workmanship of equipment does…
This inspection in context
Gloria A. Milster
1 document · 2012
Cites 110.80(a)(1) (processes and controls) more than any other section. Most of their documents are for sites in New Mexico.
The firmSunland, Inc. history
All 15 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.80(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunland, Inc.?
FDA listed 10 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.?
Gloria A. Milster, Isabel Y. Espinosa, J. Lahar and L. C. Dion are named on this Form 483, for the inspection of Sep 17 – Oct 16, 2012. Each investigator has a profile showing what they cite most.
When was Sunland, Inc. inspected by FDA?
The inspection ran Sep 17 – Oct 16, 2012, and the Form 483 is dated October 16, 2012.
How do I get the full Form 483 for Sunland, Inc.?
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