Mid Pac Foods, Inc. 9/27/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
United Parcel Service
Delivery Signature Required
September 27, 2012
Our Reference: 2915938
Patrick L. Ling, President
Mid Pac Foods, Inc.
1104 9th Avenue
Honolulu, HI 96816-2404
Dear Mr. Ling:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing facility located at 3185 Waialae Avenue, Honolulu, Hawaii between the following dates: June 15, 2012 and June 20, 2012. The inspection determined that your facility produced acidified foods and revealed that you have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114).
These significant deviations caused your acidified food products to be 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 unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The Act and regulations can be found on FDA’s webpage at www.fda.gov
As an acidified food processor, you are required to comply with the Act, and regulations relating to the processing of acidified foods and current good manufacturing practices. 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 fails to fulfill the mandatory requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements within 21 CFR Part 114.
The investigator discussed observations on the form FDA-483, Inspectional Observations, when it was issued to you on June 20, 2012. We noted the following serious violations:
1. As a commercial processor engaged in the processing of acidified foods, you must, no later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, 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). However, our inspection revealed you failed to file a scheduled process with FDA for at least one acidified food product you manufacture, specifically, All Purpose Barbeque Sauce packed in 7 oz. glass jars and 3 L plastic jugs.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
We received your July 1, 2012 response to the FDA Form 483-Inspectional Observations issued to you at the close of the inspection and acknowledge that you submitted a process filing for this product which is under technical review at the FDA Low Acid Canned Food Office. However you have not included in your response how you will ensure this problem will not recur if you begin processing a new product.
We also note that your filings for black bean sauce (SID (b)(4)); kau yuke sauce (SID (b)(4); shoyu chicken sauce (SID (b)(4)); and charisa sauce (SID (b)(4)) show a process temperature of (b)(4) for (b)(4). The filings should contain results of a challenge study supporting the (b)(4), but none was provided with the filings. Title 21 CFR 114.80(a)(1) requires that acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Your firm will need to provide challenge studies supporting the (b)(4) in order to comply with the requirements of 21 CFR 108.25(c)(2), 21 CFR 108.25(c)(3)(ii) and 21 CFR 114.80(a)(1).
2. Your firm must process each food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.25(c)(3)(i). For example, your firm has filed with FDA the scheduled process for your Black Bean Sauce product under SID: (b)(4) under FCE (b)(4). According to your scheduled process, the maximum equilibrium pH for this product is (b)(4). However, your processing records from the year 2011 to the present show pH measurements for this product ranging between (b)(4) to as high as (b)(4).
We acknowledge your July 1, 2012 response letter stating that you will be correcting this violation by adding the acidifying agent citric acid to the product to reduce the pH to the maximum pH of (b)(4). This is an adequate response and we will verify this corrective action and its effectiveness during our next inspection. However, as a reminder, you must ensure that the “equilibrium pH” of each batch of acidified product has been achieved. Also, you must have a qualified person with expert knowledge establish a scheduled process for each of your acidified products. You may find a process authority at a university on the mainland or contact one at a food association to evaluate your products.
3. Your firm must maintain processing and production records showing adherence to the scheduled processes, including records of pH measurement and critical factors intended to ensure a safe product, as required by 21 CFR 114.100(b). However, your processing records do not document all critical factors showing adherence to the scheduled processes which you had filed with FDA for four products as acidified foods: Black Bean Sauce, Kau Yuke Sauce, Shoyu Chicken Sauce, and Charsia Sauce. For example, your Black Bean Sauce product is filed with FDA under SID: (b)(4) under FCE (b)(4) with the following parameters: maximum equilibrium pH of (b)(4), process time of (b)(4) and process temperature of (b)(4). Our investigator collected your processing records from the year 2011 to the present and we found you did not document and maintain on your batch records that the critical factors including minimum process time and temperature were met.
4. Your firm must ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). However, our investigator observed that your firm’s 3 L plastic jugs including All Purpose Sauce were not marked with an identifying code.
We acknowledge your July 1, 2012 response letter stating that each individual container of the three sauces All Purpose, Charsiu, and Kalbi Sauces are now being labeled with your production code. However, you have not included in your response how you have addressed correction to any other individual 3 L containers of acidified foods besides these three sauces.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 114) and the Current Good Manufacturing Practice regulations (21 CFR Part 110).
You should take prompt action to correct the violations described in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to implement lasting corrective action on violations may result in regulatory action by FDA without further notice. The Act authorizes actions such as injunctions against manufacturers and distributors of illegal products, the seizure of such products, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state the time within which you will complete the remaining corrections.
Please send your reply to the attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Barbara J. Cassens
San Francisco District Director