- Westbrook's Cannery
- Issuing Office:
- Cincinnati District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775
December 7, 2015
Ms. Kristina L. Clark, Owner
Westbrook’s Cannery, Inc.
206 Dueber Avenue SW
Canton, OH 44706
Dear: Ms. Clark:
The United States Food & Drug Administration (FDA) inspected your food processing facility located at 206 Dueber Avenue SW, Canton, OH from June 24 – July 24, 2015. During the inspection, our FDA investigator documented serious violations of FDA’s Acidified Food regulations (Title 21 Code of Federal Regulations (CFR), Parts 108 and 114).
Based on your failure to comply with 21 CFR Part 114, we have determined that your acidified food products are 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 have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As an acidified foods processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods. These regulations are describes in 21 CFR Part 108, Emergency Permit Control, and 21 CFR Part 114, Acidified foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (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 Part 108 Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR Part 114.
You may find the Act and the regulations for Emergency Permit Control, Acidified Foods and Current Good Manufacturing Practices through links on FDA’s home page at www.fda.gov
We received your written response to the Form FDA-483 on August 7, 2015. After reviewing your response we continue to have concerns with the following significant observations:
Acidified Food Violations
- Your firm failed to ensure acidified foods are manufactured in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, your firm failed to process your acidified foods in conformity with at least the scheduled process filed under 21 CFR 108.25(c)(2) as required by 21 CFR 108.25(c)(3).
- Your firms scheduled process for all varieties of green beans (dilly beans) has a required minimum heating time of (b)(4). However, processing records revealed three lots of dilly beans, lot code 86-07 manufactured on June 22, 2015, lot codes 79-08 and 85-03 manufactured on March 16, 2015 were only processed for (b)(4). Additionally, one lot of dilly beans, lot code 86-05 manufactured on April 27, 2015 was only processed for (b)(4).
- The process times could not be determined for four lots of dill pickles, lot code 09-39 manufactured on October 22, 2014, lot code 09-40 manufactured on October 23, 2014, lot code 11-55 manufactured on October 23, 2014 and lot code 11-56 manufactured on October 24, 2014.
- The initial temperatures were not monitored or recorded for any variety of acidified pickles from June 12, 2014 – April 14, 2015 and no initial temperatures were monitored or recorded for any variety of acidified green beans ever manufactured, dated November 25, 2014 to June 22, 2015.
- Additionally, your firm’s procedure to ensure the maximum percent solids is less than or equal to (b)(4) percent reportedly is to weigh filled jars. However, you did not provide an explanation of how this procedure ensures that the critical limit (maximum (b)(4) solids) is not exceeded.
We acknowledge receipt of your undated response to the FDA FORM 483, in which you provided a form for recording processing information. We consider the form to be adequate as long as it is completed during the processing of actual products and it accurately reflects the critical factors recorded during processing.
Corrective actions should be taken to address process deviations in accordance with 21 CFR 114.89.
- You must note any departures from scheduled processes having a possible bearing on public health or the safety of the food in a separate file or log that identifies departures from the scheduled process, the action taken to correct them, and the disposition of the product involved as required by 21 CFR 114.100(c). During the inspection the investigators determined you do not maintain such a log to record departures from the scheduled process or the action taken to correct them to include the departures described above for Dilly Beans and Dill Pickles.
We acknowledge the receipt of your undated response to the FORM FDA 483. We consider the response to this item inadequate as it does not specifically state how you will ensure compliance with this regulatory requirement. Your response states you will maintain a separate deviation file, but it doesn’t identify what actions will be taken to rectify the deviation or the disposition of the product involved.
- Your firm failed to prepare current quality control procedures to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a). Specifically, the inspection revealed that your firm lacks quality control procedures to include a records review of processing and production records to ensure that the scheduled process is followed and the processing deviations are identified.
Your undated response is inadequate and your corrective action could not be verified, as you did not provide documentation of the quality control procedures your firm has implemented.
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your food manufacturing facility. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to asses and collect fees to cover FDA’s costs for certain activities, including re-inspection–related costs. A re-inspection is one or more inspection conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance had been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluation the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. Include documentation of any corrective action you have taken. 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.
Your response should be sent to: Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have questions regarding any issues cited in this letter, please contact Ms. Hunter at 513-679-2700, Extension 2134 or at firstname.lastname@example.org
Steven B. Barber