- Delivery Method:
- United Parcel Service
Recipient NameAaron Hollander
- Alle Processing Corp.
56-20 59th Street
Maspeth, NY 11378
- Issuing Office:
- Center for Food Safety and Applied Nutrition
158-15 Liberty Ave.
Jamaica, NY 11433
Dear Mr. Hollander:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 56-20 59th Street, Maspeth, NY 11378 between the dates of May 16, 2018 and May 31, 2018 where you manufacture a variety of shelf-stable and frozen low acid foods. The inspection determined you have significant deviations from the Low-Acid Canned Foods (LACF) regulations, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113).
As a manufacturer of 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 LACF products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed LACF Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code (USC) 344]. A temporary emergency permit may be required for LACF products whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113.
In addition, based upon certain criteria in 21 CFR 113, low-acid foods may be adulterated within the meaning of section 402(a)(4), [21 USC 342(a)(4)] because 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 LACF regulations through links on FDA’s Internet home page at https://www.fda.gov/.
We acknowledge receipt of your firm’s response dated June 13, 2018 to the form FDA 483 (FDA 483). The violations found during the inspection coupled with our evaluation of each of your responses are discussed below as follows:
1. Your firm failed to process each low-acid canned food (LACF) product in conformity with the schedule process, as required by 21 CFR 108.35(c)(3)(i). Specifically, on May 18, 2018, our investigator observed a temperature inaccuracy during re-calibration of one Mercury In Glass (MIG) thermometer that resulted in the potential under-processing of all LACF products manufactured by your firm between approximately February 1, 2016 through February 19, 2017. The report, dated February 28, 2018, identifies that, when re-calibrated, MIG thermometer Serial #(b) (4) read (b) (4)°F higher than the actual process temperature delivered. This instrument was installed in one of (b) (4) retorts used daily to manufacture all LACF foods produced by your company between approximately February 1, 2016 through February 19, 2017; however, your firm does not track or document which retort each specific MIG thermometer is used to monitor process temperatures and cannot isolate this instrument to one specific retort. Your firm did not evaluate this instrument re-calibration record or take any action to determine whether any affected products manufactured between approximately February 1, 2016 through February 19, 2017 and distributed into domestic commerce present a public health threat. All shelf-stable products manufactured by your firm are identified with a 4-year shelf-life from the date of packing. As a result of this instrument temperature inaccuracy, your firm did not deliver the minimum time/temperature critical limits identified in your LACF products filed scheduled processes for any LACF products manufactured between approximately February 1, 2016 through February 19, 2017.
Your firm’s June 13, 2018 written response states that every production run of LACF products between February 1, 2016 and February 19, 2017 was examined by 2 independent process authorities (PAs) and their findings were that the processes met and exceeded minimum public health sterilizing value (Fₒ) of 3 minutes or more even if the product was processed (b) (4)°F lower than the indicated set point. Although the PA evaluation appears to support these findings, your response does not address any corrective action to avoid a recurrence of this situation. The re-calibration results for the above MIG thermometer are dated February 28, 2018, so it was not until this time that this deviation was noted, and no corrective action was taken upon awareness. Your response also does not address the failure to track or document MIG thermometers used for each retort.
2. Your firm failed to equip each retort with at least one temperature indicating device that accurately indicates the temperature during processing as required by 21 CFR 113.40(b)(1). Specifically, on May 18, 2018, our investigator observed a MIG instrument temperature inaccuracy was documented on February 28, 2018 when MIG Serial #(b) (4) was determined to be reading approximately (b) (4)°F higher than the actual temperature process temperature delivered. In addition, your firm maintains no record of the specific MIG thermometer used for each retort and cannot isolate this temperature inaccuracy to specific retort.
On May 25, 2018, our investigator observed that none of your thermal process retorts are equipped with a MIG thermometer that has a valid temperature calibration. These MIGs were installed on February 20, 2017 and continue to be used in the daily thermal processing of LACF products. Five MIG thermometers installed in five retorts were observed to have expired as follows:
Retort #1 - MIG Serial # (b) (4) - Calibration expiration - 2/13/18
Retort #2 - MIG Serial # (b) (4) - Calibration expiration - 2/13/18
Retort #3 - MIG Serial # (b) (4) - Calibration expiration - 2/13/18
Retort #4 - MIG Serial # (b) (4) - Calibration expiration - 2/13/18
Retort #5 - MIG Serial # (b) (4) - Calibration expiration - 2/13/18
It should also be noted that this is a repeat observation from the previous FDA inspection, conducted on August 12, 2015, where we found a MIG thermometer installed on Retort #5 that was overdue for calibration. The tag on the unit indicated that it was last calibrated on "1/30/2014" and that it was due for calibration on "1/30/15".
Your firm’s June 13, 2018, written response states that corrective actions have commenced and are planned which include calibrating MIGs prior to running FDA LACF products, the replacement of MIG thermometers with electronic TIDs and setting up a calibration program. However, the response did not include the purchase order referenced as attached to show the type of TIDs purchased and your response does not include a time frame for the establishment of your calibration program. The MIG thermometers must be re-calibrated immediately to bring the process in compliance with the filed SIDs.
3. Your firm failed to provide the FDA information regarding the scheduled processes for each low acid food in each container size not later than 60 days after registration and prior to the packing of a new product as required by 21 CFR 108.35(c)(2). Information your firm failed to provide includes, but is not limited to, the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process.
Specifically, your firm implemented a new process schedule, developed on or about August 25, 2015, covering the manufacture of shelf-stable Gefilte Fish in Jelled Broth packed in 12 oz. semi-rigid containers that replaces an existing FDA filed process. However, you did not file this new process with FDA, as required, prior to manufacturing this product. This is a repeat observation from the previous FDA inspection, conducted August 12, 2015, where your process filing for Gefilte Fish in Jelled Broth was returned by FDA and not resubmitted by your firm for approval prior to manufacturing and distributing this product in domestic commerce. During the same FDA inspection, on August 12, 2015, FDA learned that your firm made changes to its process schedule for Whitefish and Gefilte Fish in Jelled Broth and did not notify or submit these changes to the FDA for review prior to manufacturing and distributing this product in domestic commerce.
Your firm’s June 13, 2018 written response refers to the PA review of all products processed during the period of February 1, 2016 to February 19, 2017 which found adequate processing. We also acknowledge your firm committed to no further production of the Gefilte Fish product until a new heat penetration study is conducted and the process is appropriately filed with the FDA Universal Registration and Listing System (FURLS)/LACF database. We still have not received the PA evaluation referenced in your response that documents the PA review for the Gefilte Fish subject to this new process and produced after February 19, 2017.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and 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 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 notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at email@example.com.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1