Inspections, Compliance, Enforcement, and Criminal Investigations
Wagner Provisions Co., Inc 1/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Waterview Corporate Center|
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4910
January 6, 2012
Mr. Herbold Wagner II
Wagner Provisions Company, Inc.
54 E. Broad Street
Gibbstown, New Jersey 08027-1475
Dear Mr. Wagner:
An inspection of your facility located at 54 E. Broad Street, Gibbstown, NJ was conducted by investigators from the US Food and Drug Administration (FDA) on September 21, 26-29, 2011. This inspection verified that your firm manufactures and distributes food products, specifically acidified food products.
As a manufacturer of acidified foods, 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 products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control, (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). 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 whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. In addition, based upon certain criteria in Part 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act, 21 U.S.C. § 342(a)(3), in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Your firm's failure to fulfill the requirements of 21 CFR 108.25 and mandatory requirements of 21 CFR 114 renders your Herb's Pickled Sour Onions and (b)(4) Sour Onions adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and the Acidified Food regulations through links on FDA's home page at www.fda.gov.
We have received your letter of October 6, 2011, submitted in response to the FDA-483, List of Inspectional Observations, issued to your firm at the close of the inspection. It has been made part of our official files. Our comments regarding your response follow each violation listed below.
The significant violations we found at your acidified food processing facility are as follows:
1) As a commercial processor engaged in the thermal processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm failed to have a scheduled process on file for the acidified food product, "Pickled Sour Onions in Vinegar Brine," you manufacture.
We acknowledge that your firm, in conjunction with your process authority, submitted a scheduled process filing (SID (b)(4)) on December 7, 2010; however, this process was returned on February 9, 2011, and therefore, there is no current process on file for this product at this time and a revised process needs to be submitted.
In addition, your firm fails to manufacture acidified foods in accordance with the scheduled process in violation of 21 CFR 114.80(a)(1). Specifically, the critical factor of "Maximum Percentage of Onions in Pack Brine is (b)(4) by weight" was identified in your process authority's process source letters (dated October 22, 2010 and September 28, 2011), and your firm is not monitoring the weight of the onions to ensure this critical factor is met. We acknowledge that your October 6, 2011 response includes an example of a new process record that identifies the weight of the onions as parameter to be monitored and recorded; however, this response is inadequate as you did not demonstrate that you are adhering to the scheduled process by monitoring this critical factor.
2) Your firm fails to maintain processing and production records showing adherence to the scheduled process, including records of pH measurement and critical factors intended to ensure a safe product in violation of 21 CFR 114.100(b). Specifically, the following critical factors were not monitored and recorded on processing records:
a. The pH of the Brine Solution is required to be (b)(4) and your scheduled process states that records should be maintained for the brine pH, the pH when removed from refrigeration, and the pH after 24 hours.
b. The ambient temperature of walk-in cooler #2 was only monitored once per day and it is not equipped with a continuous monitoring device. Your scheduled process indicates that "Acidification at (b)(4) to pH (b)(4) is a critical factor. On September 26, 2011, our investigators observed that the temperature of walk-in cooler #2 was at 62°F after onions had been placed in the unit. This was attributed to the fact that the cooler is only turned on during production days and it had been turned on later in the day than usual; the temperature monitoring record for September 26, 2011 indicated the unit was not in service as the check had been conducted in the morning before the unit was turned on.
c. The time and temperature for the "Thermal Processing Prior to Shipping" step in your scheduled process is listed as a critical step. Your firm had no monitoring records for the requirement to hold "for at least (b)(4) pH must be (b)(4) or lower."
We acknowledge that your response indicates that the pH of the brine solution and the temperature of the cooler will be recorded; however, as above, you failed to include completed records that demonstrate the promised corrective actions are being satisfactorily implemented. We also note that your response failed to address Observation 2c; however, we note that the thermal processing storage requirements have changed in your scheduled process dated 9/28/11. These time and temperature requirements should still be monitored as they are considered critical factors and we cannot determine if any corrective action has been implemented for this portion of the observation. The monitoring and recording of these critical factors will be verified during the next inspection of your firm.
3) Your firm fails to identify each container with an identifying code permanently visible to the naked eye in violation of 21 CFR 114.80(b). Specifically, your firm used stick-on labels to identify a "use by" date on each product container; however, the regulations state that the code shall specify the year, day and period during which the product was packed.
Your response states that you will stamp each container with a permanent ink stamp. This would be considered acceptable, except that you still intend to mark the product with a "use by" date rather than the pack date as required by the regulations. Furthermore, your response states that the outer cartons include the pack date and the use by date. Please indicate where the pack date is on the outer carton and include a label or photo of a label with your response.
This is a repeat violation, and was previously discussed with you during our inspection of September 9-21, 2010.
4) Your firm failed to prepare and maintain files on a current procedure for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying the Food and Drug Administration of any recalls; and for implementing recall programs as required by 21 CFR 108.25(e). Specifically, your firm did not have a current" completed recall procedure on file for your acidified food product, "Pickled Sour Onions in Vinegar Brine."
Your response indicates that you now have a recall procedure in place; however, a copy was not provided with your October 6, 2011 correspondence. As such, we cannot verify the stated corrective action or evaluate the procedure for adequacy.
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective actions cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the
corrections will be completed.
Failure to make prompt correction may result in enforcement action, including seizure, injunction, and emergency permit actions being initiated by FDA This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
Your reply should be sent to: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Sarah A Della Fave, Compliance Officer. If you have any questions, you may contact Ms. Della Fave at 973-331-4910.
New Jersey District
Mr. Herbold Wagner III
Wagner Provisions Company, Inc.