Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
December 22, 2015 WL # 14-16
Ms. Ieta M. Maiava
Flying Food Group, LLC.
25324 Frampton Ave.
Harbor City, CA 90710-2903
Dear Ms. Maiava:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 25324 Frampton Avenue, Harbor City, California on April 21 through May 14, 2015. During the inspection, FDA collected environmental samples from various areas in your processing facility including areas that are in close proximity to food and food contact surfaces. FDA laboratory analyses of the environmental swabs (Sample 839650) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. In addition, FDA investigators observed 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 and our findings of a persistent strain of L. monocytogenes in your processing facility between August 2011 and April 2015 cause your ready-to-eat food products to be 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 were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the CGMP regulations for foods through links on FDA's home page at www.fda.gov.
Presence of Listeria monocytogenes
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
FDA previously detected L. monocytogenes in two (2) environmental swabs collected from your processing facility during our August 2011 inspection. These environmental swabs (Sample 624067) were collected from zone 2 areas in Production Room (b)(4) including, the floor underneath a rack holding grapes along the (b)(4) Wall, and a rough spot in the floor in front of a production table. Furthermore, during FDA’s most recent inspection, eight (8) environmental swabs (Sample 839650) collected from zones 2 and 3 on April 21, 2015, including a (b)(4) tub under an apple slicing (b)(4) and a (b)(4) cart holding an apple bin in Production Room (b)(4), were found positive for L. monocytogenes.
In addition, a Whole Genome Sequence (WGS) analysis revealed that the L. monocytogenes isolated from the environmental samples collected during the August 2011 inspection, is virtually identical to the L. monocytogenes isolated from six (6) of the environmental samples collected during the most recent inspection, suggesting that L. monocytogenes has become established in the facility and persisted over time, and demonstrates your inability to remove the pathogenic organism from your processing facility.
Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, humans or machinery can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110):
1) Failure to construct, handle, and maintain equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, FDA investigators observed a (b)(4) crate directly on the floor in Production Room (b)(4) that contained raw spinach used for spinach wraps. Furthermore, Production Room (b)(4) was where Listeria monocytogenes was found in a crack in the floor. Additionally, (b)(4) crates, that can be stored directly on the floor, were observed on a (b)(4) used for assembling finished food products in Production Room (b)(4).
During the inspectional closeout meeting held on May 14, 2015, firm management stated that employees would be retrained on the placement of (b)(4) crates by May, 20, 2015. Your firm has not provided evidence that this training has been completed and that employee practices have been monitored.
2) Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1). Specifically, FDA investigators observed significant buildup of food debris on (b)(4) used to hold (b)(4) in Production Room (b)(4). (b)(4) crates were observed being stored on food processing tables in Production Room (b)(4).
During the inspectional closeout meeting held on May 14, 2015, firm management referenced the acquisition of (b)(4) which would facilitate easier cleaning. Management stated that the cleaning of the (b)(4) will need to be reevaluated, and training of employees would be completed by May 22, 2015. You have not demonstrated how you will ensure that equipment is properly cleaned and sanitized as necessary, and provide evidence that training has been completed and that employee practices have been monitored.
3) Failure to ensure equipment and utensils are designed and of such material and workmanship to be adequately cleanable, and be properly maintained, as required by 21 CFR 110.40(a). Specifically, the FDA investigators observed holes in the legs of (b)(4) located in Production Room (b)(4), of which the legs appeared to be hollow. Furthermore, gapping was observed underneath the tables in Production Room (b)(4) and between the support brace and (b)(4) of the table in the (b)(4) Room, making cleaning difficult.
During the inspectional closeout meeting held on May 14, 2015, firm management stated that 90% of the production tables would be replaced with new tables. We will verify the adequacy of your corrective actions at a follow-up inspection.
4) Failure to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act, as required by 21 CFR 110.35(a). Specifically, FDA investigators observed gapping between two sections of wall molding located against the (b)(4) wall in Production Room (b)(4) and gapping between two sections of wall molding located against the (b)(4) walls in the (b)(4) Room.
During the inspectional closeout meeting held on May 14, 2015, firm management stated that any deficiencies with wall molding would need to be reported by the Sanitation Manager and spot checked during the monthly audits. We will verify the adequacy of your corrective actions at a follow-up inspection.
This letter may not list all the violations at your facility. 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. You are responsible for ensuring that your products are in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond in writing within fifteen (15) working days of receiving this letter. Your response should outline the specific steps you are taking to correct these violations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions your firm has taken. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Your firm’s response should be sent to:
CAPT Daniel Cline, Acting Director
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Dr. William Vitale at 949-608-2919.
Steven Porter, Acting Director
Los Angeles District
Mr. Milt Liu, President and CEO
Flying Food Group, Inc.
212 N. Sangamon Street
Chicago, IL 60607
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413