DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE{S) OF INSPECTION 60 8th St NE Atlanta, GA 30309 (404) 253-1161 03126 - 4/11118 FEI NUMBER 2000023438 Industry Information: wwvv.fda.gov/oc/industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO: Nathan K. Nickolisen, Complex Manager FIRM NAME STREET ADDRESS Rose Acre Farms - Hyde County Egg CITY, STATE AND ZIP CODE 1560 Hyde Park Canal Road TYPE OF ESTABLISHMENT INSPECTED Pantego, NC 27860 Shell Egg Producer THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE($) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS; AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE OBJECTION OR ACTJON WITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT FDAAT THE PHONE NUMBER AND ADDRESS ABOVE. DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED: Observation 1: When your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods were not used to achieve satisfactory rodent control. Specifically, a review of your pest control records from September 2017 to present indicate an ongoing rodent infestation. The corrective actions taken by your firm have not been effective at reducing the rodent levels within your poultry houses to an acceptable level that is below the threshold established in your SE Prevention Plan. Additionally, the following conditions were observed in the poultry houses: On 03/26/2018: •House 9 - one (1) live apparent rodent in manure pit while swabbing about halfway down row two (2) in the pit, and one (1) live apparent rodent observed running across the upper level floor last row 1O; two (2) dead apparent rodents observed on the ground, 10+ feet from the front of the houses; daylight observed through an area with spray foam creating a potential pest entrance in the manure pits around the closed roll up door at the front of the house near row four (4). • House 13 - multiple live apparent rodents running around the staging area in pit, and burrowing in and out of manure piles; five (5) live apparent rodents observed in the manure pits. EMPLO~EE(S) N.~~~ ~N.:1 TITLE /Priqt ...,,..- fl-. \·... t "- I { . 0 SEE REVERSE OF THIS PAGE or Type) DATE ISSUED i v FORM FDA 483 (•JUO/ ""?"IWUS E'" 1~oSOLUE / Page 1 of4 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD ANO DRUG ADMINISTRATION DATE(S) OF INSPECTION DISTRICT OFFI CE ADDRESS AND PHONE NUMBER 03/26 - 411 1/18 60 8tb St NE Atlanta, GA 30309 (404) 253-1161 FEI NUMBER 2000023438 Industry Information: www.fCla.gov/oc/industry NAME AND TITLE OF INDMDUAL TO WiOM REPORT IS ISSUED TO : Nathan K. Nickolisen, Complex Manager FIRM NAME STREET ADDRESS Rose Acre Fanns - Hyde Cou nty Egg 1560 Hyde Park Canal Road CITY, STATE ANO ZIP CODE TYPE OF ESTABLISHMENT INSPECTED Shell Egg Producer Pantego, NC 27860 On 03/27/2018: • House 2 - one (J) live apparent rodent, downstairs in row 4 , pit area. • House 6 - one (1) live apparent rodent, in row I, pit area. • House l O- approx imately 4-5 apparent live rodents in the pit were observed near the staging table and several were observed while dragging swabs, in the pit area; more than 10 apparent rodents observed in pit staging area including baby mice. • Approximately five (5) apparent rodents seen while walking rows during swab collection; also, a large spill/pile of what appeared to be feed witb large flying insects too numerous to count between house numbers 10 and 11, directly beside canal . •House 11 - one (1) live apparent rodent in manure p it while swabbing approximately halfway down row 5; possible apparent rodent burrows observed in the manure piles; apparent dead rodent carcass on row 5; possible apparent rodent hole/bun-ow observed in the large gravel in the front of the house; and 1 apparent live rodent on the bird p latform. On 03/28/201.8: • House 5 - three (3) live apparent rodents were observed downstairs, in rows 4 & 5. • House 8 - two (2) Iive app arent rodents were observed downstairs, in rows 4 & 1. Observation 2: There were insanitary conditions and poor employee practices observed in the egg processing facility that create an envirorunent that allows for the harborage, proliferation and spread of filth and pathogens throLLghout the facility that could cause the contamination of egg processing equipm.ent and eggs. Specifically, On 03/28/ l 8, a rev iew of t he firm's sanitation procedure, Cleaning Procedure fo (b) (4) Form# 6. 7 .0 F-3, Version #3, found that the procedure for cleaning thf(b ) (4) in the egg processing fac ility was not being i!J!Plemented by management and fo llowed by sanitation employees. Employees were observed bypassing th e (5) (4) step, and observed spraying on the detergent and immediately w iping off, not allowing the detergent to soak for t he prescribed(b) (4 )minutes. EMPLOYEE($) SIGNATURE S1=E REVERSE OF THIS PAGE - iL ll:f ·1\. l EM PLOYEE(S/ NAME AND TITLF (Print or Type) \ ·- "'· r ~ ;, 1 •I t . . '·J /, /Jffe'f , /. :f .;_.,.,.,.,,,.. >~ /"<'t.·IRA. ·."'/I ( I l .• , • / ~· " ....',(I ~. -/ .. ~ :'_.) 7 '.1 . , FORM FDA 483 (9/0 . (~ .- r 2.. ::. <... ~ u .....-, .•.. · /1J..')r/ ~ · >c ~· r "" , • ··'' " ,. · .1 DATE ISSUED I (..I ( l I '<) Page 2 of4 / DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRU G ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 60 8th St NE Atlanta, GA 30309 (404) 253-ll61 03/26 - 4/11/18 FEI NUMBER 2000023438 Industry Information: www.fda.gov/oc/industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO: Nathan K. Nickolisen, Complex Manager FIRM NAME STREET ADDRESS Rose Acre Farms - Hyde County Egg 1560 Hyde Park Canal Road CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT JNSPECTED Pantego, NC 27860 Shell Egg Producer On 03/28118, during a review of the firm's cleaning procedures and a walkthrough of the cleaning procedures we observed that the firm did not have in their procedures or use a sanitizing step following the wash step. Throughout the inspection we observed condensation dripping from the ceiling, pipes, and down walls, onto production equipment (i.e crack detector, egg grader) and pooling on floors in foot traffic and forklift pathways. On 03/28/18, we observed maintenance and sanitation employees placing buffers (food contact) and metal covers to the egg packer with buffers (non-food contact) onto floor, pa11ets, and equipment that was visibly dirty with accumulated grime and food debris, before placing the equipment into service. Additionally, throughout the inspection several production and maintenance employees were observed touching non-food contact surfaces (i.e. face, hair, intergluteal cleft, production equipment with accumulated grime and food debris, floor, boxes, trash cans, inedible transport cans) and then touch shell eggs and food contact surfaces (i.e. buffers, rollers, etc.) without changing gloves or washing hands. We a lso observed maintenance employees dragging non-food contact equipment (i.e. black electrical conduit with accumulated grime and dried food debris) on top of food contact surfaces (i.e. conveyors and rollers). Throughout the inspection we observed equipment (i.e. conveyor belts, chains, rail guards, buffers, egg transpott arms, egg clappers, production computers and ex"terior of production equipment surfaces) with accumulated food debris (i.e. dried egg and shells) and grime, post sanitation. The same areas of accumulated food debris were observed uncleaned on multiple days during the inspection pre-and post-sanitation. On 03/28/18, we observed a sanitation employee on the right line, packing area, lane (o) (4)utilizing a steel wool scrubber to scrub debris off egg buffers in service, post sanitation. The steel wool scrubber was stored on a cart in a dustpan that had a pool of water and egg mix with floating food debris and grime. EMPLOYEE(S) NAME AND TITLE (Print or Type) SEE REVERSE OF THIS PAGE FORM FDA 483 ( .. ·Jc·· ... ., ,., / . ' .: ' /.~·~ .., · ''-~· n .. ~ '} .. . . r~ t1:;, i'U , ··.'1 ~ • ;~·~ .. ...,;.,_/' r' !'···" ,.: ' Page 3 of 4 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 60 8th St NE Atlanla, GA 30309 (404) 253-116 1 03/26 - 4/1 1118 FEI NUMBER 2000023438 Industry Information: www.fda.gov/oc/industry NAME AND TITLE OF INDMDUAL TO WHOM REPORT IS ISSUED TO: Nathan K. Nickolisen, Complex Manager FIRM NAME STREET ADDRESS Rose Acre Fanns - Hyde County Egg 1560 Hyde Park Canal Road CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED Pantego, NC 27860 Shell Egg Producer Throughout the inspection we observed at least 25 flying insects throughout the egg processing facility. The insects were observed landing on food, food contact surfaces, and food production equipment. On 03/28/18, we observed an employee mix and use a sanitizer on food contact equipment that was not prepared according to the manufacturer instructions. When tested with a ~aternary ammonia test strip, the sanitizer was · found to be 1500ppm, outside of the acceptable range ofi