Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/michael-zakany-llc-07282015
Timestamp: 2020-08-07 15:03:06
Document Index: 570104505

Matched Legal Cases: ['arts 108', 'art 110', 'art 108', 'art 114', '§ 3440', 'art 108', 'art 114', 'art 114', '§ 342', 'art 110', 'arts 108', 'art 110', '§ 379', '§ 379']

Michael Zakany LLC - 07/28/2015 | FDA
Michael Zakany LLC - 07/28/2015
Michael Zakany LLC July 28, 2015
Michael Zakany LLC
Michael Zakany, LLC
Dba Jose Madrid Salsa
CIN-15-455640-22
Dear Mr. Zakany:
The United States Food and Drug Administration (FDA) inspected and collected samples at your food processing facility located at 601 Putnam Avenue, Zanesville, OH, from February 20 through March 3, 2015. Our investigator determined you are a manufacturer of acidified foods. 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. The inspection revealed serious violations of the Acidified Food regulations (Title 21, Code of Federal Regulations (CFR), Parts 108 and 114) and the current Good Manufacturing Practice (cGMP) regulations for food (21 CFR Part 110). We acknowledge your firm’s voluntary recall of 123/13 ounce jars of Jose Madrid Salsa brand Black Bean Corn Poblano Salsa, lot 601 1601 080515 and receipt of your undated written response concerning the observations noted on the Form FDA 483, Inspectional Observations that was issued to your firm. We find your response inadequate as further described below.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods. These regulations are described 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. § 3440]. 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 registrations and filing of process information, and mandatory requirements of 21 CFR Part 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.
Additionally, based on your failure to comply with 21 CFR Part 110, we have determined that your food products are 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 may have become contaminated with filth, or whereby they may have been rendered injurious to health.
You may find the Act and other relevant regulations through links on FDA’s Internet home page at http://www.fda.gov.
1. A commercial processor engaged in processing acidified foods in any registered establishment shall process each food in conformity with at least the scheduled processes filed under 21 CFR 108.25(c)(2) in order to comply with 21 CFR 108.25(c)(3)(i). However your firm failed to process your acidified foods in conformity with at least the scheduled processes filed under 21 CFR 108.25(c)(2). Specifically,
a. Your firm’s filed scheduled process for Black Bean Corn Poblano Salsa, (b)(4) has a maximum pH of (b)(4). However, samples collected by FDA show that the Salsa manufactured under lot number 601 1601 with expiration date 080515 had pH ranging from (b)(4).
b. On 2/24/2015, our investigator observed that you added (b)(4) to acidify your Black Bean Corn Poblano Salsa. The scheduled process lists (b)(4) as the acidifying agent. Further, your formula sheet lists (b)(4) as the acidifying agent.
Your undated written response does not address this deviation as it merely states that employees will be trained to properly prepare ingredients. Corrective actions should be taken to address the process deviation in accordance with 21 CFR 114.89.
2. Your firm failed to have personnel involved in acidification, pH control, heat treatment, and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner as required by 21 CFR 108.25(f). Specifically, our investigator observed that your firm manufactures Black Bean Corn Poblano Salsa while your firm has not completed a Better Process Control School, or, you were not under the supervision of someone who has completed a Better Process Control School.
Your undated written response does not address this deviation.
3. Your firm failed to test and examine containers often enough to ensure that containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, you do not do any destructive testing, such as vacuum or security testing, on your glass containers with metal closures of acidified foods. Your examination of containers of acidified product consists only of a visual check of safety buttons on the lids.
Your undated written response does not address this deviation. We acknowledge your response contains documentation concerning post-process container handling; however, this information appears to be general information taken directly from the FDA website. The document does not include information relating to your firm’s specific operations and does not list who is responsible for container examination or the number of containers to be examined.
4. Your firm failed to maintain records identifying initial distribution of finished product as required by 21 CFR 114.100(d). Specifically, the investigators observed that you do not track initial distribution for any of your acidified food products. For example, on 02/17/2015, you recalled Jose Madrid Salsa brand Black Bean Corn Poblano Salsa, lot 601 1601 080515, manufactured on 08/05/2014, and you could not determine with certainty the customers that received the recalled lot because you did not record initial distribution of the lot.
Your undated written response does not address this deviation as it does not contain a description of any procedure to assure that the lot numbers are recorded in the future.
5. Your firm failed to maintain records of the examination of raw materials, packaging materials, and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels as required by 21 CFR 114.100(a). Specifically, you do not examine ingredients or receive supplier's guarantees or certificates, or examine glass jars or metal lids for compliance before using them to manufacture your acidified salsa.
We acknowledge that your undated written response states that employees will be trained to properly handle ingredients, jars and lids; however, this response is inadequate because it is not specific to your firm’s operation in that it fails to describe what constitutes proper handling, examination or acceptance criteria at your facility.
6. Your firm failed to prepare and maintain current procedures for recalling products that may be injurious to health; for identifying, collecting, warehousing and controlling products; for determining the effectiveness of recalls; and for notifying FDA, and implementing recall programs as required by 21 CFR 108.25(e). Specifically, the inspection of your firm on 02/20/2015 revealed that you did not have any written recall procedures in place.
Your undated written response does not address this deviation because the procedure submitted appears to be merely a reiteration of the FDA guidance and is not specific to your firm’s operations. For example, it does not list who at your firm is responsible for gathering any data, submitting it to FDA or determining the root cause of the problem.
1. Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated as required by 21 CFR 110.10(b)(3). Specifically, on 02/24/2015, our investigator did not observe any employees wash their hands at any time during manufacturing of Black Bean Corn Poblano Salsa, lot 601 1601 022416. Further, an employee was observed licking salsa off his hand and then continuing to cap jars of salsa without first washing his hands.
Your undated written response included a document entitled “Training and Cleaning Policies,” which appears to address general cleaning and the failure of employees to wash and sanitize their hands. However, it is not adequate because it is not specific to your firm’s operations.
2. All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source as required by 21 CFR 110.80. Specifically, on 2/24/2015, the investigator observed the following:
a. Employees touching the inside of empty glass jars with their bare hands to pick the jars up prior to filling them with Jose Madrid Salsa brand Black Bean Corn Poblano Salsa, lot 601 1601 022416.
b. Two employees wiping salsa off the outer finish of glass jars with their bare hands. This was observed after the jars were filled with Jose Madrid Salsa brand Black Bean Corn Poblano Salsa, lot 601 1601 022416.
c. Employees touching the inside of metal lids with their bare hands before capping jars of Jose Madrid Salsa brand Black Bean Corn Poblano Salsa, lot 601 1601 022416, with the lids.
d. Numerous plastic buckets and lids, used to transfer salsa from one kettle to another, stored inside the bathroom.
Your undated written response included a document entitled “Training and Cleaning Policies,” which appears to address general cleaning and the failure of employees to wash and sanitize their hands. However, it does not address the deviation because it is not specific to your firm’s operations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the acidified foods regulation (21 CFR Parts 108 and 114) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product, enjoin your firm from operating, and/or issue an Order of Need to obtain and hold a Temporary Emergency Permit.
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. Reinspection-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)]. 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 send your reply to the U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Stephen J. Rabe, Compliance Officer. Should you have any questions concerning this letter, you can contact Mr. Rabe at 513-679-2700 ext. 2163 or by email at stephen.rabe@fda.hhs.gov.