| Public Health Service Food and Drug Administration |
New England District One Montvale Avenue |
Department of Health and Human Services
WARNING LETTER
CMS #228454
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
December 6, 2011
Leah Cook, Director of Operations
Crown O'Maine Organic Cooperative
960 Maine Street
Vassalboro, Maine 04989
Dear Ms. Cook:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility located at Vasalboro, Maine, on August 10 through September 8, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice (cGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated with the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 342(a)(4). Accordingly, your smoked salmon, smoked mussels, smoked haddock, and smoked shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
Seafood HACCP
1) You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have HACCP plans for your refrigerated smoked salmon, smoked mussels, smoked haddock and smoked shrimp to control the food safety hazards of pathogen growth and undeclared allergens (i.e., to ensure declaration of the appropriate fish species).
2) You must maintain sanitation control records that, at a minimum, document monitoring and correction set out in 21 CFR 123.11(b), to comply with 21 CFR 11(c). However, your firm did not maintain sanitation monitoring records for safety of water; condition and cleanliness of food contact surfaces; prevention of cross contamination; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food from adulterants; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests.
Current Good Manufacturing Practices
1) Failure to take effective measures to exclude pests from the processing areas of your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). During the inspection, FDA collected samples of oat groats, rye flour and mill waste, and received the laboratory analyses on August 22 and 23, 2011 that confirmed rodent and insect filth in and around food. These sample results and the following observations from our inspection revealed CGMP deficiencies that cause your products to be adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C § 342(a)(4):
a) In your dry storage area, oat groats in a 50 lb, three-layer paper bag had a -2 inch hole near the top seam. Marks on the hole indicate it was from rodent gnawing. Hairs on the hole were from a rat or mouse. The bag near the hole tested positive for urea. The product beneath the hole contained rat/mouse excreta pellets and was positive for urea. Rat/mouse pellets too numerous to count were found in the area between the pallet of oat groat bags and the west wall of your dry storage room. There were apparent rodent excreta pellets on the oat groat pallet and in an open box of loose oat groats on the pallet. (Sample 686777)
b) Approximately fifteen (15) apparent rodent excreta pellets were observed on top of spilled grain observed beneath a pallet of jars of blueberry preserves and bottles of canola oil. This pallet was located approximately 10 feet south of the oat groats described in a) along the west wall.
c) Approximately 5 feet south of the spilled grain in b), beneath a product rack along the west wall there were -20 apparent rodent excreta pellets. To the south and directly next to the rack there was a rodent trap set along the west wall. In the area of the trap there were apparent rodent pellets too numerous to count. A pallet of wheat flour in 50 lb paper bags was adjacent to the area.
d) A pallet of 50 lb three-layer bags of whole wheat flour was stored near shelves along the east wall of your dry storage room. There were apparent rodent gnaw holes through cardboard at the base of the pallet and into two bags at the base of the pallet.
e) In your storage area adjacent to your main office there was a 738 lb plastic mesh bag of oat and wheat mill waste. There were rat/mouse pellets too numerous to count intermingled with the product. Laboratory analysis determined that the product had been eaten by pests. There were dead adult and larval moths in the product. There were also arthropod excreta in the product. There were live and dead moth-like insects on the product bag. (Sample 686779)
f) Five other bags of grain mill waste with weights ranging from 878 lb to 2803 lb were stored in the same area as the oat and wheat mill waste in e) above. All five bags had live and dead moth-like insects on the packaging and in the products.
We acknowledge that you voluntarily destroyed products on August 29, 2011 based on sample results that showed rodent and insect contamination.
2) Failure to ensure that the plant buildings and structures are suitable in size, construction, and design to facilitate maintenance and sanitary operations, as required by 21 CFR 110.20(b)(4). However, our investigator observed a -1/2 inch gap at the base of your freezer door. Improper closure of the door leads to frozen condensate buildup on surfaces of packaging materials and the ceiling. Thawing condensate near the door was dripping onto a pallet of blueberries. The packages had holes that allowed for both the buildup of frozen condensate on the berries and for the entrance into the packages of dripping condensate from the ceiling.
3) Failure to provide, where necessary, adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).
Specifically, you keep the doors to your facility open at all times during production without any screening to prevent the entrance of pests from the outside, including:
a) Doors to your two loading bays in the storage room that contains your freezer. A strip curtain hangs in the doorway between the storage room with the freezer and the dry storage room.
b) The facility's front door, which leads to a hallway that connects to the area where the firm stores bags of mill waste. A strip curtain hangs in the doorway between the mill waste storage area and your dry storage room.
c) The door to the loading bay in the area where you store bags of mill waste.
d) Additionally, a window on the west wall of your facility was open -1 inch and there was no screen to prevent the entrance of pests.
4) Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations, as required per 21 CFR 110.35(b)(1). Specifically, in the northeast corner of the dry storage room you had stored a 5 gallon bucket partially full with hydraulic oil near pallets and packaging materials used for food. In the dry storage room, near the door to the freezer room you had stored an open tote container of kerosene near boxes and plastic bags used for packaging.
5) Failure to maintain buildings and keep them in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a)]. Specifically,
a) The east and west walls of the dry storage area had a build-up of food or other residue and an uneven surface due to chipping paint. Packaged foods, packaging materials and open containers of produce (tomatoes, garlic, and dry beans) are stored along this wall.
b) There are extensive cracks in the concrete down the center of the dry storage area in the center of the floor and in through the cooler door. The cracks extend out to the east and west walls in dry storage. There was a build-up of soil in the cracks. Products are stored over the cracks and employees routinely move over the cracks during operations.
c) The floor is pitted and worn to a rough and uneven surface around the shipping and receiving bays. There is a build-up of soil in the rough areas. Food products pass through these areas during shipping/receiving operations.
d) There is exposed fiberglass insulation on a beam above the walkway to the shipping/receiving bays. Products pass under the exposed insulation when moving in and out of this area.
The above violations are not intended to be an all-inclusive list of violations in your plant. You are responsible for ensuring that you manufacture products in compliance with the Act and all of its implementing regulations, including the seafood HACCP regulation (21 CFR 123) and the CGMP regulation for food (21 CFR Part 110). You are also responsible for using procedures to prevent further violations of the Act, all applicable regulations, and all other requirements of federal law.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in regulatory action being initiated by FDA without further notice. For example, we may seize your products and/or enjoin your firm from operating.
You should notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long-term, corrective action, such as revised sanitation standard operating procedures, measures to prevent entry of pests into your facility, changes to your current pest control services, documentation of completed building repairs, and employee training logs. If you cannot complete all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-587-7487.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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