Emily A. Brune
- Starlight Desserts Inc
2001 West Garfield Street
Pier 91, Building 28, Mailbox #C-92
Seattle, WA 98119
- Issuing Office:
- Seattle District Office
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
March 21, 2018
In reply, refer to: CMS 548336
Emily A. Brune, President
Starlight Desserts Inc.
2001 West Garfield Street
Pier 91, Building 28
Seattle, Washington 98119
Dear Ms. Brune:
The United States Food and Drug Administration (FDA) inspected your bakery located at 2001 West Garfield Street, Pier 91, Building 28, Seattle, Washington, on February 7, 2018, through February 13, 2018. During the inspection, the FDA investigator documented 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 110).
This inspection revealed that food manufactured at your facility, including eclairs, Napoleon cakes, lemon mini cakes, and biscotti, is 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 it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. You can find the Act and its associated regulations through links in FDA’s home page, www.fda.gov
The serious cGMP violations observed during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to you at the close of the inspection. We received a letter from your firm dated February 27, 2018, written in response to the Form FDA-483. We address your response below, in relation to each of the noted violations. The violations observed included the following:
1. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically,
a. On February 7, 2018, a live rodent was observed running across the east end of the production area, into the laundry room and into a hole in the wall at the northeast corner of the room.
b. On February 9, 2018, a live rodent was observed running up a water pipe on the east wall of the production area, adjacent to the three-compartment sink and hand wash sink. The rodent was then observed running down the pipe, over to a hose on the north wall of the production area, then into the laundry room and into a hole in the wall on the northeast corner of the room. Cleaned and sanitized baking sheets were stacked and drying by the three-compartment sink and by the metal table on the north wall adjacent to the hose used by the rodent.
c. On February 7, 2018, rodent excreta pellets were observed throughout your facility.
i. At least ten apparent rodent excreta pellets were observed behind the oven on the north wall of the production area.
ii. Eleven apparent rodent excreta pellets were observed throughout the laundry room, where clean wash rags and aprons are stored.
iii. Thirty-seven apparent rodent excreta pellets were observed on and among unused equipment stored at the west end of the production room. Additionally, apparent rodent excreta pellets too numerous to count were observed on a table top in the same area. The unused equipment can be a harborage for pests.
The FDA sample INV 1037889, collected during the inspection, was analyzed by FDA’s Pacific Northwest Laboratory. The analysis of this sample confirmed the presence of rat excreta pellets. The visual observations and the analytical results for this sample confirm the presence of rodent activity within your facility.
We reviewed your response and find it partially adequate. Your response states that you have patched the holes in the ceiling, cleaned the rodent excreta pellets and sanitized surfaces, covered the trench area, and asked the pest company to provide extra protection to the entire building, which included placing additional traps in areas showing evidence of rodents. However, your response did not provide any documentation of these corrections or details on how your firm intends on preventing this violation from recurring. It is unclear from your response how you will ensure the corrections you completed are adequate to correct the pest activity, such as increased pest control monitoring.
2. You failed to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time that their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically,
a. On February 7, 2018, an employee was observed touching his face and then returning to handling ready-to-eat eclairs and cream filling without washing his hands.
b. On February 7, 2018, an employee was observed touching her glasses and then returning to packaging biscotti without washing her hands.
c. On February 7, 2018, an employee was observed handling biscotti with a bare hand that was bandaged. She was observed removing the bandage and continuing to package biscotti without washing her hands.
We reviewed your response and find it partially adequate. Your response states that employees have been retrained to wash hands thoroughly any time a non-food contact surface comes in contact with their hands. However, your response did not provide any documentation of this training or how you will monitor to ensure the training is adequate to prevent this violation from recurring.
3. You failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically,
a. On February 9, 2018, apparent dough residue was observed on the dough sheeter after (b)(4) sanitation was conducted. The sheeter was last used to process cherry almond biscotti dough and is also used to prepare puff pastry, a dough that does not contain almonds.
b. On February 9, 2018, dough residues were observed on the edge of the (b)(4) north prep station and on the (b)(4) south prep station after (b)(4) sanitation was conducted.
We reviewed your response and find it partially adequate. Your response states that the equipment has been cleaned and that the edges and sides will be included in the daily cleaning of the dough sheeter. However, your response did not provide any documentation of this correction, such as a revised cleaning schedule. Your response states that the edges, shelves, and underside of tables will be wiped down and sanitized at the same time tabletops are cleaned, which is often multiple times a day. However, your response did not provide documentation of this correction or how your firm will prevent this violation from recurring.
4. You failed to maintain building fixtures and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from being adulterated, as required by 21 CFR 110.35(a). Specifically, on February 7, 2018, the interior of the stove hood was observed with a build-up of dust and debris directly above the stove and prep table where uncovered in-process foods are prepared. Employees were observed melting chocolate and gelatin, heating cream, and preparing blueberry topping on the stove directly below the hood.
We reviewed your response and find it partially adequate. Your response states the hood above the stove will be included when the stove is thoroughly cleaned, which is (b)(4) unless needed sooner. However, your response does not provide documentation of this correction, such as a revised cleaning schedule, or how your firm will prevent this violation from recurring.
5. You failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition, as required by 21 CFR 110.37(d)(1). Specifically,
a. On February 7, 2018, in the men’s restroom, the floor was observed soiled in front of both toilets, the urinal, and both sinks. One of the toilets was observed soiled. A toilet brush was observed on the hand wash sink. No hot water was available at the hand wash sinks and no paper towels or hand drying device were observed. The trash can was observed with overflowing toilet paper tubes, used paper towels, and other waste.
b. On February 7, 2018, in the women’s restroom, the floor was observed soiled in front of the toilets and hand wash sinks. One hand wash sink had a build-up of dust and debris. No hot water was available at the hand wash sinks and you explained to the investigator that it takes approximately seven minutes to receive hot water in the restrooms.
We have reviewed your response and find it partially adequate. Your response states the restrooms have been cleaned and a cleaning schedule posted. Your response states that paper towels and soap have been stocked. However, your response does not provide documentation of this correction, such as the cleaning schedule, or how often the restrooms will be cleaned. Your response does not address how your firm will prevent this violation from recurring, such as increased monitoring. Your response states that you are (b)(4), but did not provide a timeframe for correction or what you are doing in the interim to provide adequate hand washing facilities for your employees.
6. You failed to ensure the plant and facilities are constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4). Specifically,
a. On February 7, 2018, apparent black mold residue was observed on the wall and along the base of the window above the three-compartment sink in the production area. On the other side of the same wall in the laundry room, the wall appeared to be rotting and had an approximately two-inch hole in the wall.
b. On February 7, 2018, the drop-in ceiling panel in the northeast corner of the laundry room was observed to be missing. The exposed walls and support beams above the missing panel appeared to be wet and moldy. Dirt-like material was observed directly below the missing panel on the countertop and sink in the laundry room. Multiple drop-in ceiling panels were also observed missing throughout the storage area south of the production room, including directly over cardboard packaging material.
c. On February 7, 2018, stagnant, foul-smelling water was observed pooled in the trench drain near an unused walk-in cooler. The trench drain extended into the adjacent business and was not covered or screened.
d. On February 7, 2018, water was observed seeping from the west side to the east side of the walk-in cooler, where food was being stored.
e. On February 7, 2018, a hole was observed in the wall at the northeast corner of the laundry room. As previously stated, a rodent was observed entering this hole.
f. On February 7 and 9, 2018, the exterior door on the west side of the building was observed not fully closed with a ¼ inch by three foot gap along the bottom and side of the door.
We reviewed your response and find it inadequate. Your response states the building manager has committed to fix many of the issues; however, no further details were provided on what these corrections may entail or how the they will correct the violations. Your response states that new ceiling tiles have been ordered and will be installed. However, your response does not address how you will prevent this violation from recurring or address the apparent wet and moldy walls and support beams observed above one of the missing ceiling tiles. Your response states that you have sealed the cooler and that it has remained dry for a week; however, you did not provide documentation of this correction. Your response does not address the gap observed at the exterior door on the west side, which was observed not fully closed during the inspection.
This letter is not intended to be an all-inclusive list of the 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 the Act and FDA regulations. We note that similar deviations were observed on the previous FDA inspection.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-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 Jessica L. Kocian, Compliance Officer. If you have any questions regarding this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.
Miriam R. Burbach
Program Division Director
cc: Washington State Department of Agriculture
Food Safety Program
1111 Washington Street, 2nd Floor
Olympia, Washington 98504-2560
 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.