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WARNING LETTER

Rosemark Bakery, Inc. MARCS-CMS 523139 —


Recipient:
Rosemark Bakery, Inc.

United States

Issuing Office:
Minneapolis District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Minneapolis District
250 Marquette Avenue, Suite 00
Minneapolis, MN 55401
(612) 334-4100 

 

April 25, 2017
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                                        
Refer to MIN 17 - 07
 
 
Carol A. Rosemark
Owner
Rosemark Bakery, Inc.
1728 Duluth Street
Maplewood, Minnesota  55119
 
Dear Ms. Rosemark:
 
The Food and Drug Administration (FDA) conducted an inspection of your wholesale bakery manufacturing facility located at 258 Snelling Avenue South, St. Paul, Minnesota, from December 22 through January 12, 2017. During the inspection FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (21 CFR), Part 110.1  
 
At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection.  Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm’s food products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov
 
Your significant adulteration violations under section 402(a)(4) of the Act are:
 
1.    You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. However, some of your products contain wheat, soy, egg, or milk allergens, yet you have no allergen control program in place, such as scheduling production based on allergens, using dedicated equipment, or cleaning between products.
 
2.    You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).  However, on December 20, 22, and/or 27, 2016, our investigators observed the following:
 
A.  Extensive apparent insect webbing on the ceiling throughout the packaging room where finished bread product is cooled and packaged;
B.  Three small flying insects within approximately 12 inches of the mixer as bread dough was mixed;
C.  Ten apparent rodent excreta pellets, approximately 1/3 inch in length, on the left side of a dock door in the production room;
D.  Bags of flour and other ingredients stored next to an open service door. The screen door that covered the service entrance had gaps of approximately 1 inch along the bottom and 1/2 inch on the right side running from the base of the door to approximately one-third of the way up;
E.  Eight dead, winged insects on the basement hallway floor between the women’s restroom and the basement ingredient storage area.
Within the facility’s unused cooler:
F.  Mounds of dirt with apparent insect burrows;
G.  Six winged insects and other apparent insects, too numerous to count, embedded in discarded shortening in the cooler;
H.  Apparently molted insect exoskeletons, too numerous to count, adhered to sides and lid of an unlabeled white plastic bucket in the cooler;
I.  Dead winged insects, too numerous to count, on the floor of the walk-in cooler.
 
Furthermore, your facility does not conduct pest control and does not contract with a pest control service.
 
3.    You must maintain buildings, fixtures, utensils, and other physical facilities in a sanitary condition and in sufficient repair to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a).  However, on December 20, 22, and/or 27, 2016, our investigators observed the following:
 
A.  The majority of the packaging room floor was covered with a layer of food residue that is approximately 1/4 to 1/2 inch thick.  Rolling racks of finished product were observed cooling on top of the layer of food residue in this room.
B.  The packaging room drain was plugged with food residue.  Discolored water containing debris was pooled around the drain approximately 4 feet from uncovered finished product.  Additionally, rolling racks containing packaged finished product were observed in the pooled water.
C.  The ceiling throughout the packaging room was deteriorated directly above open and exposed finished products such as French Bread.
D.  There was an unidentified mold-like substance on the ceiling of the packaging room where exposed finished bread products were cooling.
E.  Dust build-up was observed on the walls and ceiling throughout the packaging room where exposed finished bread products, such as French Bread, were cooling.
F.  The flooring of the production room was deteriorated and a crack ran the width of the production room floor between the conveyer and south wall near the cooler door.  The deteriorated flooring was up to 1 inch deep and 6 inches wide, exposing the floor aggregate. This aggregate was partially filled with food residue and debris.
G.  Water was running out from the south set of proofer doors and it pooled on the floor between the packaging and production rooms.  The floor had significant apparent food residue build-up.  The nearest drain was occluded by debris.  Employees walked through the pooled water as they went between the production and packaging rooms.  Rolling racks were stored near the drain in pooled water, and plastic crates with packaged finished product were stored directly on the floor in pooled water next to the proofer.
H.  Debris, equipment, utensils such as dough hooks and knives for cutting dough, and empty ingredient packaging were accumulated throughout the production room.  The debris included empty ingredient packaging, old clothing, rags, empty bags, and boards.
I.  Production machines, including but not limited to the mixer, dough divider, dough rounder, overhead proofer, sheeter, conveyer, rolling racks, and tables in the production room, were coated with built-up food residue.
J.  The fan blades and blade covers, which are used to cool finished product in the packaging room, were covered with an accumulation of dust.  The fans were observed blowing directly on exposed finished product from approximately 6 inches away.  The fans are situated between the pooled water of the plugged drain in the packaging room and finished product.
K.  A deteriorated brush with extensive dust and apparent food residue build-up was used to brush off the food contact surface of the bread cutter machine.  Finished bread product was then observed being cut with the bread cutter machine.
L.  The exterior of the three cutting machines had extensive areas of chipped or worn off paint.
M.  The foreman used a rag to swab the inside of the divider hopper with soy oil.  After swabbing, the rag was placed on the top of the dough divider which had a build-up of food and oil residue.  The rag was repeatedly dipped in a bucket of soy oil, then used to swab the hopper, and then placed on the filthy divider.  Between swabs, raw dough was fed into the dough divider through the hopper.
N.  Soy oil was running out of the dough divider, creating a pool approximately 6 feet long and 3 feet wide on the floor.  Employees were observed walking through and standing in the pool of soy oil, then walking throughout the production facility.
O.  The conveyer belt between the divider and rounder machines and the conveyer on the sheeter machine had worn and rough surfaces.  Additionally, the belt of the large conveyer was worn and frayed on the edges, rendering the equipment difficult to clean.  The equipment was observed being used to produce French Bread on December 22, 2016.
P.  The water hose used to add water to the mixing bowl while making French Bread had extensive food residue build-up.  The hose was stored between the mixer and broken dough roller, and hooked on what appeared to be equipment lines.  The hose was dragged across the production floor and the hooked nozzle at the end of the hose was attached on the inside of the mixing bowl as water was added as an ingredient.
Q.  The three compartment sink had standing, cloudy, water in the sanitize tub with a thick white substance floating in it.  
 
4.    You must take effective measures to protect against the inclusion of metal in food, as required by 21 CFR 110.80(b)(8).  However, our investigators observed the use of metal bread pans with holes and jagged edges which protruded into product during the production of French Bread.
 
5.    You must ensure that employees wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). However, on December 22, 2016, our investigators observed the following:
 
A.  A production employee rolled raw dough in a pan of oats and moved to the packaging room and handled finished bread without washing her hands at any time.
B.  During a five hour production period employees worked throughout the firm, handled raw ingredients, in-process product, and finished product  without being observed washing their hands.
C.  The foreman handled donut dough with bare hands.  No hand washing was observed over a four hour period he made donuts. During that time period, he was observed touching equipment surfaces that were covered in dried, accumulated food residue, touching unclean non-food contact surfaces such as doors and filing cabinets, and moving between the production room, packaging room, retail area, and basement.
 
6.    You must provide effective hand cleaning and sanitizing preparations, as required by 21 CFR 110.37(e)(2).  However, on December 22, 2016, our investigators observed that two of the three hand wash sinks in the production room had no soap.  None of the hand wash sinks had sanitizer.  There were no towels or other means to dry hands at the hand wash sinks near the mixers and ingredients.
 
7.    The plant must be constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(4). However on December 22, 2016, our investigators observed condensate dripping in the area between the divider and the rounder. Condensate was running down beams and duct work throughout the production area, and condensate droplets were observed directly above the divider, rounder, and main conveyer.
 
8.    You must maintain toilet facilities in sanitary condition, as required by 21 CFR 110.37(d)(1). However, on December 20, 2016, our investigators observed winged insects flying in the men’s room and two dead, winged insects on the floor of the men’s room.  There was no soap or sanitizer in the men’s room.  The sink, urinal, and toilet were visibly unclean with brown and black residue throughout, and extensive black residue and was built up on the floor.
 
9.    You must provide safety-type lighting fixtures over exposed food, as required by 21 CFR 110.20(b)(5).  However, our investigators observed multiple fluorescent light tubes without safety coverings over areas where raw and uncovered finished product is handled.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. Please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to Dianna C. Sonnenburg, Compliance Officer, at the address listed in the letterhead. If you have questions regarding any issue in this letter, please contact Ms. Sonnenburg at (612) 758-7125.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District
 
 
xc:   
David E. Rosemark
Foreman
Rosemark Bakery, Inc.
258 Snelling Avenue S.
St. Paul, MN 55105-2045
  
__________
1 Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule).  An establishment will continue to be subject to Part 110 until the Part 117 compliance date applies according to the size of the business.  See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.
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