Inspections, Compliance, Enforcement, and Criminal Investigations

Blue Heron Bakery 3/23/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021 

 

March 23, 2018                               
 
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, refer to: WL CMS 548340
 
Evan J. Price, Owner
Blue Heron Bakery
4419 Harrison Avenue NW, Suite 108
Olympia, Washington 98502
 
WARNING LETTER
 
Dear Mr. Price:
 
The United States Food and Drug Administration (FDA) inspected your bakery located at 4419 Harrison Avenue NW, Suite 108, Olympia, Washington, on November 28 through December 6, 2017, and again on January 25 through February 1, 2018. FDA investigators observed serious violations of the current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).[1]  At the conclusion of each inspection, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We have not received any correspondence from your firm in response to the FDA-483s.
 
Based on FDA’s findings during the inspection, we determined that your food products are adulterated within the meaning of section 402(a)(4) 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 been contaminated with filth or rendered injurious to health. You may find the Act and its associated regulations through links in FDA’s home page at www.fda.gov.
 
We note the following significant deviations:
 
1.    You failed to take effective measures to exclude pests from your processing areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators documented evidence of rodent activity near food storage and preparation areas in your food processing facility. For example, on January 26, 2018, the following were observed in the production area and storage room of your facility:
 
a)  Eight Rodent Excreta Pellets (REPs) were observed on the floor behind the mixer along the north wall, west of the three compartment sink and east of the ingredient batching station.
b)  Eight REPs were observed on plastic bin lids and on a wood block stored under the dough roller in the southeast corner of the production area, approximately one foot from the dry ingredient storage rack and west of the exit. This area houses the ingredient storage rack and the (b)(4) dough proofers.
c)  Three REPs were observed in the frame of the dough roller located west of the exit in the southeast corner of your facility. This area houses the ingredient storage rack and the (b)(4) dough proofers.
d)  Three REPs were observed on the floor along the south wall in the southeast corner of your facility and approximately six inches from the dry ingredient storage rack. This area houses the ingredient storage rack and the (b)(4) dough proofers.
e)  Two REPs were observed on the floor in the southeast corner of your facility and on the east side of the commercial oven. This area houses the ingredient storage rack and the (b)(4) dough proofers.
f)  Seven REPs were observed on the floor along the east wall of your facility behind the dishwasher.
g)  Thirteen REPs were observed on the floor along the east wall of your facility, under and behind a rolling metal cart approximately two feet to the south of the commercial dishwasher.  Clean bread loaf pans are stored on this rolling metal cart.
h)  Two REPs were observed on the water heater support shelf above the utility sink in the storage room off the north side of the production area.
 
FDA sample INV 1037887, collected on January 25, 2018, during the current inspection, was analyzed by FDA’s Pacific Northwest Laboratory. The analysis of this sample confirmed the presence of REPs and confirmed the presence of rodent activity within your facility. 
 
Similar conditions were observed during our previous inspection, and listed on an FDA-483 issued to you at the conclusion of the inspection on December 6, 2017. For example, REPs were observed in the production area on the belt of the dough roller located near the storage rack; on the floor along the south wall in the southeast corner; and on the floor below the three compartment sink. This is not a comprehensive list of the areas where REPs were observed during our previous inspection, but areas where we continued to observe REPs during the current inspection.
 
2.    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed that the rear exterior door to the facility was propped open to the outside each day of the inspection without adequate protection to prevent entry of pests into the production facility.
 
3.    Your firm’s employees failed to wear hair restraints and beard covers where appropriate, as required by 21 CFR 110.10(b)(6). Specifically, our investigator observed two employees with facial hair working in the production area, handling in-process wholesale breads and cookies, without beard covers or hair nets. This is a repeat observation from the November 28 through December 6, 2017, inspection. 
 
4.    Your firm’s employees failed to adequately store personal belongings so that they were not in an area where food is exposed and equipment or utensils are washed, as required by 21 CFR 110.10(b)(7). Specifically,
 
a.  On January 25, 2018, our investigator observed an employee’s coat hanging from an empty bread cooling rack in the production area.  This was also observed during our previous inspection.
b.  On January 26, 2018, our investigator observed an employee’s coat, and two uncovered beverage containers on the north corner of the prep island in the food production area. 
c.  On January 29, 2018, our investigator observed a set of keys, two uncovered beverage containers, and an employee’s personal food item on the north corner of the prep island in the production area. An employee was observed pureeing vegetables on the same prep island approximately one foot away from these articles.
 
This letter is not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and FDA regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action being initiated without further notice, including, without limitation, seizure and/or injunction.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. Re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections. 
 
Your firm’s response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of LCDR Cynthia White, Compliance Officer. If you have questions regarding this letter, please contact LCDR White at (425) 302-0422.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
Program Division Director

[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 applicable to its business size. See https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.

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