- FSS, Inc. dba Food Service Specialties
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
June 18, 2015
Via UPS Overnight Delivery
Refer to MIN 15 - 12
Stephen Lineer, President and Co-owner
Donald Leick, Vice President and Co-owner
FSS, Inc. dba Food Service Specialties
5202 Moundview Drive
Red Wing, Minnesota 55066-1139
Dear Messrs. Lineer and Leick:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 5202 Moundview Drive, Red Wing, Minnesota, on December 10, 11, 15, 18, 2014, and January 5 and 9, 2015. The inspection found that your firm manufactures a variety of low-acid canned food products including Salsa Con Queso Sauce, Cheese Dip, White Queso Sauce, and Alfredo Sauce packaged in glass jars, and acidified food products including Alfredo sauces, snack dips and cheese sauces packaged in glass jars and flexible pouches. Other products produced include high-acid, shelf-stable pasta, pizza and barbecue sauces and refrigerated, dairy-based Alfredo sauces packaged in glass jars, flexible pouches and bulk totes. Our inspection determined that you have significant deviations from the Low-Acid Canned Foods regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR Part 113), from the Acidified Foods regulations, 21 CFR Part 114, as well as deviations from the current Good Manufacturing Practices regulations, 21 CFR Part 110.
As a manufacturer of acidified foods and low-acid canned food (LACF) products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food and low-acid canned food products. These regulations are described in 21 CFR Part 108, Emergency Permit Control, in 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for acidified foods and low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113 and 114.
In addition, based upon certain criteria in 21 CFR Parts 113 and 114, LACF and acidified foods may be adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the acidified and low-acid food regulations through links on FDA’s Internet home page at http://www.fda.gov.
Deviations from the LACF regulations, 21 CFR Parts 108 and 113, related to your LACF operation include the following:
1. Your firm failed to process each low-acid canned food in conformity with at least the scheduled process, as required by 21 CFR 108.35(c)(3)(i). Specifically, the filed processes for the products:
A. Cheese Dip (SID# (b)(4)), Salsa Con Queso Dip (SID # (b)(4) and SID # (b)(4)), Monterey Jack Queso Dip (SID # (b)(4)), Jalapeno and Cheddar Cheese Dip (SID # (b)(4)) and Classic Alfredo Sauce (SID # (b)(4)) identify the critical factors of viscosity and minimum headspace:
i. Viscosity measurements are obtained using the (b)(4) Method; a value of (b)(4) at (b)(4)°F is identified in the filed processes. Review of selected thermal processing records indicates that viscosity measurements are not obtained at a temperature of (b)(4)°F.
ii. For each of the products, the source documentation from the firm’s Process Authority identifies a minimum pre-processing headspace value of (b)(4) inch at (b)(4)°F. Review of the record Jar Line Weight and Temperature Check Log-SSHE Retort indicates the headspace measurements are not obtained at (b)(4)°F.
B. Salsa Con Queso Dip (SID # (b)(4)) and Cheese Dip (SID # (b)(4)) identify the critical factor, maximum fill weight of (b)(4) ounces. Review of the record Jar Line Weight and Temperature Check Log-SSHE Retort dated 10/2/14 for these products indicates maximum fill weights above (b)(4) ounces.
2. Your firm failed to measure and record critical factors at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process, as required by 21 CFR 113.40(e)(7). Specifically, the filed processes for the following products identify the critical factor minimum rotation speed.
A. Cheese Dip (SID # (b)(4)): review of the records (b)(4) Sterilization Report and Retort Processing Log dated 10/2/14 indicates that during sterilization the rotation speed was not electronically documented nor was it manually recorded.
B. Classic Alfredo Sauce (SID # (b)(4)): review of the record Retort Processing Log dated 11/6/14 indicates that the rotation speed and stopwatch time were not manually documented during sterilization. Further, review of the record Retort Processing Log dated 11/5/14 indicates the stopwatch time was not manually documented during sterilization.
3. Your firm failed to determine and record with sufficient frequency the initial temperature of the contents of the containers to be processed to ensure that the temperature of the products is no lower than the minimum initial temperature specified in the scheduled process, as required by 21 CFR 113.87(c). Specifically, during each retort cycle, the container used to measure IT is nested with additional containers in an insulated cooler, which does not reflect the worst case conditions.
4. Your firm failed to plainly mark, with a heat-sensitive indicator or other effective means to indicate visually to thermal processing personnel those units that have been retorted, as required by 21 CFR 113.87(b). Specifically, each retort basket is not identified with a heat-sensitive tag or other effective means to visually indicate that a thermal process was applied to the retorted containers.
5. Your firm failed to record results of the glass container capper cold water vacuum test, as required by 21 CFR 113.60(a)(2). Specifically, low-acid products are packaged in glass containers. A cold water vacuum test of the (b)(4) closing machine is not performed prior to the start of filling operations.
6. Your firm failed to perform at sufficient frequency proper closing machine performance and consistently reliable hermetic seal production, as required by 21 CFR 113.60(a)(3). Specifically, security examinations are performed on glass jars of finished product; however, the firm’s security values are lower than the supplier’s recommended security values. Values that are below the minimum usually indicate under-application of the lugs.
7. Your firm failed to maintain records of accuracy checks of temperature-indicating devices specifying standard used, method used, and person performing the test, as required by 21 CFR 113.40(e)(1). Specifically, a review of calibration records dated 4/28/14 for the temperature-indicating device (a (b)(4) digital temperature gauge) did not identify the standard or method used to perform the calibration.
8. Your firm failed to record, in a separate file or log, process deviations involving a failure to satisfy the minimum requirements of the scheduled process, and the actions taken, as required by 21 CFR 113.89. Our investigators’ review of your processing records for production of Mild Cheddar Cheese Dip and Cheese Dip on October 2, 2014, show two process deviations of LACF products where the maximum fill weight of (b)(4) oz. were exceeded. No process deviation records, including corrective actions, were maintained by your firm.
9. Your firm failed to adequately maintain instruments used for regulating and recording conditions that control or prevent the growth of undesirable microorganisms, as required by 21 CFR 110.40(f). Specifically, the following instruments associated with the (b)(4) rotary water immersion retort are not calibrated or maintained:
A. the two sensors controlling and monitoring the rotation speed of the retort;
B. the flow meter located on the water re-circulation loop; the flow meter also controls the pump stack light which indicates that water is being pumped through the re-circulation loop;
C. the RTD controlling the automatic steam control valve on the upper drum;
D. the check valve located on the compressed air lines;
E. NIST traceable stopwatches are not utilized to time the rotation speed of the retort.
We received your firm’s responses to the FDA-483 dated January 22, February 26, and March 6, 2015, and acknowledge your firm’s attempts to correct the LACF violations. In addition, we understand you have suspended retort operations for LACF products at this time and that you promised to fully correct all of the violations identified above prior to resuming production of any LACF products. However, at this time, your corrections are inadequate in that you have not provided adequate documented evidence of your corrective actions to ensure your compliance with 21 CFR Parts 108 and 113. Most importantly, you failed to address how your firm handles process deviations in accordance with 21 CFR 113.89 in that you provided no information concerning the affected product (i.e., review of process deviations by a competent authority, maintaining a separate deviation record and status of product disposition).
Deviations from the Acidified Foods regulations, 21 CFR Part 114, related to your acidified foods operation include the following:
10. Your firm failed to manufacture acidified food in accordance with the scheduled process, as required by 21 CFR 108.25(c)(3)(i). Specifically, your Guacamole Style Dip (SID # (b)(4)) identifies:
A. the critical factor minimum jar temperature of (b)(4)°F. Your operating parameter is (b)(4)°F. Review of the record Jar Line Weight and Temperature Check Log-SSHE dated 5/15/14 indicates a minimum jar temperature of (b)(4)°F at (b)(4);
B. the critical factor process temperature of (b)(4)°F. Your operating parameter and divert is (b)(4)°F. Review of the circular chart dated 6/4/14 indicated at (b)(4) the process temperature was (b)(4)°F. The system did not divert. Further review of the record Jar Line Weight and Temperature Check Log-SSHE indicated that the corresponding LED digital display read (b)(4)°F at (b)(4), a (b)(4) degree difference between the chart temperature and the digital display temperature yet the same RTD feeds the chart and the digital display. Therefore, the exact process temperature cannot be determined.
C. the critical factor maximum flow rate of (b)(4) pounds per minute to ensure the residence time in the hold tube is achieved ((b)(4) minutes at (b)(4)°F). The flow rate through the hold tube is determined by the jar fill rate. The pump speed is not documented or validated to ensure the residence time of (b)(4) minutes in the hold tube required for Guacamole Style Dip is achieved.
Your firm’s January 22, 2015, response indicates that your operator mistakenly recorded the temperature when the system was not running jars and that your investigation revealed that your chart recorder was recording lower temperatures than actual because of a mechanical problem and that you replaced the chart recorder; however, you failed to provide assurance that the processing records for the associated batches of product were evaluated by a competent authority. In addition, your March 6, 2015, response states that you have added a frequency drive to your system so that the maximum flow rate is not exceeded; however, you failed to indicate how you intend to monitor and record this critical factor in accordance with 21 CFR 114.100(b).
11. Your firm failed to ensure all reasonable precautions are taken to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically, effective measures are not taken to protect against the inclusion of glass in finished product. For example, in the Glass Jar Filling Room on 12/11/14 the air blower was not functioning during the manufacture of acidified product; glass jars were not air blown or inverted prior to filling. In addition, our investigators observed a jam on the conveyer leading to the closing machine which caused several jars to fall and break; however, the operator did not conduct a thorough inspection of the conveyor after the incident.
Your January 22, 2015, response stated that you reviewed your procedure for hand feeding/loading glass jars and re-trained all affected employees; however, you failed to provide details of what the training entailed and failed to provide an explanation of why the glass jars were not handled in a safe manner.
This letter is not intended to be an all-inclusive list of deficiencies in your plant and your product labels. It is your responsibility to ensure that all of your products comply with the Act, the Low-Acid Canned Food (21 CFR Parts 108 and 113), Acidified Food (21 CFR Part 114), and the Current Good Manufacturing Practice (21 CFR Part 110) regulations, and any other applicable regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as imposition of a temporary emergency permit, seizure or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
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.
Your response should be sent to the U. S. Food and Drug Administration, Attention: Demetria L. Lueneburg, Compliance Officer, at the address listed on this letterhead. If you have any questions with regard to this letter, you may contact Ms. Lueneburg at (612) 758-7210.
Michael Dutcher, DVM
Close Out Letter