Inspections, Compliance, Enforcement, and Criminal Investigations
Sterling Foods LLC 4/8/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District |
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone (510) 337-6700
VIA UNITED PARCEL SERVICE
April 8, 2013
John D. Likovich
Chief Executive Officer
Sterling Foods LLC
1075 Arion Parkway
San Antonio, TX 78216
San Antonio, TX 78216
Dear Mr. Likovich:
The Food and Drug Administration (FDA) conducted an inspection of your facilities located at 33300 and 33333 Western Avenue, Union City, California, between February 20 and February 28, 2013. During our inspection, an FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been 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 FDA regulations through links in FDA's homepage at www.fda.gov.
Current Good Manufacturing Practice
1. As required by 21 CFR 110.80(b)(8), you must take effective measures to protect against the inclusion of metal or other extraneous material in food. However, our investigator observed the following:
- On February 20, 2013, during the production of your (b)(4) Blueberry Bagels and February 25, 2013 during production of your (b)(4) Plain Bagels on Bagel Line 1, the mesh-belt conveyor carrying bagels through the proofer was seen broken or missing pieces in several places. The shape and size of the missing pieces of mesh-belt conveyor material is consistent with reported customer complaints your firm received from 2009 to 2013. Your firm’s forensic reports on four of these complaints documented the measurement of the metal fragments to be over 7mm in length.
- On February 21, 2013, during production of your Multigrain Snack Bread on your MRE (Meals Ready to Eat) line, several metal spikes were seen broken and/or missing from the metal cylindrical aerator used to perforate the in-process dough. There was no metal detector or other protective measure in place to detect metal.
- On February 20, 2013, and February 25, 2013, production personnel working on Bagel Lines 1 and 2 were seen changing the metal detectors parameter settings. After the change to the parameters, the respective metal detectors failed to detect the controls used to verify the machines were functioning properly.
We acknowledge that during the inspection your firm voluntarily conducted a stock recovery and re-screened all products produced on Bagel Lines 1 and 2 from February 17 - 25, 2013 using the parameter settings you mentioned during the close-out meeting with our investigator. However, you did not report if any product had been rejected nor did you report any results of your controlled runs. In addition, you have not demonstrated what corrective actions will be taken when a metal inclusion is detected.
You told our investigator that you are considering adding a metal detector to your MRE line. You explained that the metal detector parameters on Bagel Lines 1 and 2 have been set to consistently detect all controls, as well as a 7mm piece of mesh-belt conveyor. You also stated that you have modified the metal detectors to prevent unauthorized parameter changes, and have implemented a metal detector parameter change log. However, you did not address employee training or steps to be taken when the devices fail to detect controls. Had our investigator not brought the observations above to your attention, it is likely that the metal detectors would still fail to function properly. There is little assurance that the changes you have made are effective without verification.
You also told our investigator that your firm will be strategizing on ways to improve protection against metal inclusion in your products. Based on our observations during our inspection, it does not appear that you have conducted a validation study to determine appropriate settings for your metal detectors. The use of electronic metal detectors is complex. The type and orientation of the metal object in the food affects the ability of the equipment to detect it. Processing factors may also affect the conductivity of the product and create an interference that may mask metal inclusion unless the detector is properly calibrated. You should consider these factors when calibrating and using this equipment. Visual equipment checks may also be used in your process for protection of metal inclusion in product. Monitoring your equipment (mesh-belt conveyors, nuts/bolts, equipment with metal to metal contact) to ensure parts are present and secure should be conducted with adequate frequency.
2. As required by 21 CFR 110.80(b)(1), you must maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing. However, our investigator observed the following:
- The stacking machine brushes on Bagel Lines 1 and 2 and the conveyor belt from cooling to packaging on Bagel Line 2 were seen embedded or stained with food debris after completion of your cleaning procedures. These pieces of equipment come into direct contact with all finished bagel products. Harmful microorganisms may remain viable on improperly cleaned and sanitized food contact surfaces, equipment, and utensils and may lead to contamination of the food products with which they come in contact.
- During the quality assurance check on Bagel Line 1 (dough mixing and dividing equipment), and the Bagel Line 2 (hopper and dough divider), the ATP (adenosine triphosphate) swabs resulted in RLUs (relative light units) well over your established threshold of (b)(4) RLUs (observed RLU values ranged between 40 - 581). Employees were seen spot cleaning the swabbed areas and then swabbing those same areas. The practice of spot cleaning equipment to ensure RLU values are acceptable appears to be a common practice. Your firm is not following your own procedure to ensure that your equipment is properly cleaned and sanitized before use in production.
We acknowledge the shut-down of Bagel Line 2 and the re-cleaning of the entire line after an RLU of 581 was detected.
During the close-out meeting, your sanitation manager told our investigator that the brushes on Bagel Lines 1and 2 had been re-cleaned and that your SSOPs will be modified to include proper cleaning of the brushes and the Bagel Line 2 conveyor. He also stated that sanitation employees are being retrained on cleaning procedures, including re-cleaning the entire piece of equipment when ATP readings are high. He is also investigating more effective sanitizers. The adequacy and sustainability of these corrective actions will need to be verified in our next inspection.
3. As required by 21 CFR 110.80(b)(5), you must handle all work-in-process in a manner that protects against contamination. However, our investigator observed trays of unpackaged whole wheat sandwich thins being stored 10 inches from the ground. An employee was seen sweeping the floor 2 feet away, creating airborne dust and debris which could contaminate these unprotected food products. Employees were then seen placing these whole wheat sandwich thins onto the conveyor for packaging.
4. As required by 21CFR 110.20(a)(1), you must 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. However our investigator observed the following:
- At 33300 Western Avenue, several large bins holding rotting food waste and water which harbored flies and other insects were stored in the parking lot. Piles of debris, such as old food products, cardboard boxes, and plastic trays on and around metal racks were also stored against the exterior south wall. These items create an attractant and inhibit the ability to monitor for pests.
- At 33333 Western Avenue, several large bins holding food waste with a fly hovering above them were stored in the northwest corner. A garbage can located at the outgoing loading dock was seen overflowing with trash and was left unattended during the duration of this inspection. These items create an attractant for pests.
5. As required by 21CFR 110.20(b)(7), you must provide adequate screening or other protection against pests. However our investigator observed the following:
- At 33300 Western Avenue, an exterior door leading to the bagel packaging area was left open, with an unlocked screen door that had several ¼ inch gaps around the frame. A loading dock door on the west was left partially open, exposing a one foot gap. An exterior wall fan on the east wall was left with louvers in the open position. These different gaps could allow pests access to your facility.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
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.
Your written response should be directed to:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number (CMS case 394763) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
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 closeout 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.
Darlene B. Almogela
Acting, District Director
Michael J. Cunningham
Director of Plant Operations
33300 Western Avenue
Union City, CA 94587
Director of Plant Operations
33300 Western Avenue
Union City, CA 94587
Close Out Letter