Questions & Answers Concerning 483 Inspectional Observations
Below is information related to the Salmonella Enteritidis Outbreak in Shell Eggs - May 2010.
Updated September 3, 2010
On August 30, 2010, FDA issued inspectional observational reports through Wright County Egg and Hillandale Farms of Iowa. This means the current inspections are concluded and these documents are mandated by law to issue at the conclusion of the inspection. The reports list significant, objectionable conditions observed by FDA’s investigators.
Below is a series of questions and answers addressing the findings of the 483 reports:
Q: When is a 483 issued?
A: A 483 is issued when investigators observe any significant objectionable conditions. Our investigators are trained to ensure that each observation noted on the 483 is clear, specific and significant. The observations are cited when in an investigator’s judgment these conditions or practices observed indicate that an FDA-regulated product is in violation of FDA’s requirements. This could be such as when a food is being produced, prepared, packed or held under conditions whereby it may become contaminated with filth or maybe rendered injurious to health.
Q: What is the purpose of a 483?
A: The 483 notifies the company of objectionable conditions and is presented and discussed with the company’s senior management with the goal of seeing changes made quickly.
Companies are encouraged to respond in writing with their corrective action plan and then implement that corrective action plan expeditiously.
Q: Is the 483 intended to be an all-inclusive list of every possible deviation from law and regulation?
A: No, it’s not. It’s a report - this report doesn’t include observations of questionable or unknown significance at the time of inspection. There may be other observations that exist. But our investigators note what they saw during the course of the inspection and rely on the company to take full corrective action of any deviations that these 483 observations may represent.
Q: How is the 483 shared with the company?
A: These 483s have been discussed with the company’s management. A discussion ensued August 30, 2010 at Wright County Egg and August 27, 2010, when the Hillandale Farms 483 was issued to discuss each observation so that they have a full understanding of what the observations are and what they mean.
Q: Are shell eggs still being shipped to consumers from either of these companies/facilities?
A: These companies have informed FDA that they will not ship shell eggs to consumers until FDA is confident the eggs are safe for consumption.
Q: What are the implications of the 483 for agency enforcement and what happens next?
A: The 483 does not constitute a final Agency determination of whether any condition is in violation of the Federal Food, Drug and Cosmetic Act or any of our relevant regulations.
The 483 is considered along with what is known as an Establishment Inspection Report or EIR which will be prepared by our investigational teams. The EIR includes inspectional evidence that will be considered in totality of the overall situation.
The Agency will consider all of this information and then determine what further action if any is appropriate.
Quality Egg LLC is the legal name of the business in Iowa, which includes a number of layer farms, pullet farms and a feed mill.
The (layer) farms operate as Quality Egg LLC, Wright County Egg Division. The pullet farms operate under Quality Egg LLC, (DeCoster) Farms or (DeCoster) Feed Mill and are DBA’s (Doing Business As) Quality Egg LLC’s for the Quality LLC Feed Mill which supplies feed for Wright County Egg Division and also to Hillandale Farms.
Generally speaking the names are often used interchangeably among Quality Egg, Wright County Egg and (DeCoster) Farms.
Among the observations noted by FDA investigators at Wright County Egg were the following:
Failure to fully implement and follow procedures in its Salmonella Enteritidis Prevention Plan. Examples include:
- Failure to prevent stray poultry, wild birds, cats and other animals from entering poultry houses. Outside access doors to manure pits were pushed out by the weight of manure which was piled in some cases four to eight feet high thereby providing openings into the poultry houses for wildlife or other animals.
- Animals, including rodents, were able to enter the poultry houses due to structural damage that included things like missing siding and air vents or gaps at the bottom of doors.
- Failure to eliminate birds from laying houses and to control rodents or flies: investigators observed bird nests and birds in one poultry house, live rodents in at least one poultry house at several plants, and live and dead flies that were too numerous to count in poultry houses at certain plants.
- Live flies were observed on and around egg belts and walkways to different sections of the egg laying areas.
- Live flies were crushed underfoot when employees walked in the aisles at work and there were live and dead maggots observed in the manure pit at one plant.
- Investigators observed the failure to implement practices to protect against the introduction or transfer of Salmonella Enteritidis between and among poultry houses.
- Specifically, investigators observed a lack of separate entrances to each poultry house, thus requiring the use of shared corridors between certain houses.
- Employees were observed failing to change protective clothing when moving from one house to another, and failed to clean and sanitize equipment prior to moving between poultry houses at one plant.
The 483 for Hillandale covers observations made at two separate plants, each consisting of multiple houses. This inspection was conducted August 19-26, 2010.
Among the observations noted by FDA investigators:
- Failure to fully implement and follow procedures in its Salmonella Enteritidis Prevention Plan. Examples:
- Failure to eliminate entryways for rodents and other pests into the egg production facilities. Failure to bait and seal rodent burrow holes in the egg production facilities and to eliminate the potential rodent or pest harborage places near the structures.
- Failure to eliminate standing water adjacent to the manure pits or to eliminate liquid manure.
- Investigators observed that the company failed to maintain documentation that 19-week-old pullets were monitored for Salmonella Enteritidis, or raised under SE-monitored conditions.
- Failure to take steps to make sure that SE isn’t transferred into or among poultry houses: Investigators observed uncaged hens tracking manure from the manure pits to the caged house areas.