Sunland, Inc.
Form 483 issued April 10, 2009 · Portales, New Mexico
- Inspection
- Mar 9 – Oct 9, 2009
- Investigators
- Larisa E. Pavlick· Steven C. Mader
- Observations
- 6
- Pages
- 2
- FEI number
- 1000117188
In short: On April 10, 2009, FDA issued a Form 483 with 6 observations to Sunland, Inc. in Portales, New Mexico (FEI 1000117188) after an inspection that ran Mar 9 – Oct 9, 2009. The investigators were Larisa E. Pavlick and Steven C. Mader. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
5 of 6 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (2×) · 110.10 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to manufacture foods under conditions and controls necessary to minimize the potential…
- 02
All reasonable precautions are not taken to ensure that production procedures do not contribute…
- 03
Failure to wear beard covers…
- 04
Employees did not wash/sanitize hands after each absence…
This inspection in context
Larisa E. Pavlick
2 documents · 2009
Cites 110.10 (personnel) 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
See how FDA wrote the same problem up elsewhere.
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.?
Larisa E. Pavlick and Steven C. Mader are named on this Form 483, for the inspection of Mar 9 – Oct 9, 2009. Each investigator has a profile showing what they cite most.
When was Sunland, Inc. inspected by FDA?
The inspection ran Mar 9 – Oct 9, 2009, and the Form 483 is dated April 10, 2009.
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.