Los Angeles District Office
Irvine, CA 92612
UNITED PARCEL SERVICE
March 9, 2017
Mr. Chay Kour, Owner
C & B Croissants Corporation
1339 W. Gaylord St.
Long Beach, CA 90813-1320
Dear Mr. Kour:
During an inspection of your firm located at 1339 W. Gaylord St., Long Beach, CA on October 25 through November 4, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of frozen croissants. During the inspection, the investigator found violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and its implementing regulations at www.fda.gov.
Violations revealed during the inspection include, but are not limited to, the following:
1. Your firm failed to take 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, our investigator discovered evidence of insect and rodent activity near foods stored in your food processing facility. For example, the following items were discovered in the production areas of the bakery during the inspection:
a. In the weighing/ ingredient storage room off the main processing room there were about 8 apparent rodent excreta pellets on an unused slicer adjacent to a gnawed package (containing a video); and approximately 13 apparent rodent like excreta on the floor beneath the unused slicer. The table holding the slicer was about 12 feet away from uncovered buckets holding dry ingredients used to make plain croissant dough for the current day’s production.
b. In an enclosed room directly adjacent to the processing room, approximately 5 live cockroaches (less than 1” long each) were observed. In addition, apparent rodent excreta pellets were observed in the northwest corner (30 approximately), northeast corner (17approximately), and center of the room (12 approximately). No food or food packaging material was stored in this room; only small pieces of dried dough like residue.
c. Front and back roll-up doors remained open during the first day of the inspection, with no barriers to prevent pests and vermin from entering the warehouse areas in both the front and the rear of the building.
d. About 3 birds flew through the front warehouse door into the warehouse and then flew out (this is a repeat observation from the FDA inspection in 2010).
e. One fly near the 3 compartment sink in the processing room and 3 flies on a table near the employee break room.
2. Your firm failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically,
a. Uncovered dough was stored directly under ice build-up in the walk in freezer.
b. Uncovered dough was stored in a walk-in cooler with dark residue on the grills covering the fans.
3. Your firm failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, our investigator observed that boxes used for packaging frozen croissants were stored in contact with the wall and floor in the main processing room.
4. Your firm failed to maintain all plant equipment and utensils, as required by 21 CFR 110.40(a). Specifically, our investigator observed that the conveyor belt on one of the dough sheeters (flattener) was torn and in disrepair.
5. Your firm failed to store raw materials in a manner that protects against contamination and minimizes deterioration, as required by 21 CFR 110.80(a)(1). Specifically, our investigator observed the following observations inside the walk-in cooler:
a. Two boxes of margarine had stained markings and material on the tops of these containers that appeared to be bird like droppings/excreta.
b. A plastic crate with residue stored on top of boxes of margarine, including personal food items including opened plastic beverage bottles.
c. Trays of uncovered margarine were observed being stored directly on aluminum trays, including one tray that appeared dirty with spots of dark residue.
d. Uncovered sliced margarine was stored on the top shelf of a plastic cart that appeared soiled.
6. Your firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically,
a. Aluminum trays used to hold flattened dough appeared to have dark residue which appeared to rub off on the plain croissant dough that was placed onto at least one tray.
b. The pastry wheel cutter used to cut the croissant dough had visible dark residue around the screw.
c. The conveyor used to process strawberry croissants on the previous day had red residue on the conveyor belt and dark residue next to and under the belt.
d. One of the dough mixers' control panel had dried dough build-up.
In addition, your firm only uses soap and no sanitizer for cleaning.
7. Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically,
a. Cases of empty milk cartons and empty strawberry filling containers with dried food residue were stored next to the front roll-up door.
b. Empty flour bags with visible flour were stacked on a cart near the front warehouse door.
c. A pallet of empty milk containers was being stored outside near the back warehouse door.
8. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically,
a. Dark mold like residue was observed near the bottom of the freezer door and behind the coving/baseboard to the right of the freezer door.
b. The wall behind the strawberry conveyor had visible dried red residue.
We note that you have not provided a response to the FDA 483 issued to you on November 4, 2016. Without a response, we are unable to assess any potential corrective actions.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance.
Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations and to prevent these violations or other similar violations from occurring again. Include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the date by which you will have completed the corrections.
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. A 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 send your reply to:
Kelly D. Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have questions regarding any issue in this letter, please contact Mr. Robert McNab at (949) 608-4409. Please reference CMS number 518530 in your response.
CDR Steven E. Porter, Jr.
Los Angeles District Director
David M. Mazzera, PhD, Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435