WARNING LETTER
Kaltec Food Packaging Inc.
MARCS-CMS 553493 —
June 08, 2018
Recipient:
Recipient Name
Ms. Harriet L. Mascara
Kaltec Food Packaging Inc.
36-40 Center St.
Port Jervis
,
NY
12771
United States
Issuing Office:
New York District Office
United States
Office of Human and Animal Food Operations East
Division 1
WARNING LETTER
CMS# 553493
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 8, 2018
Ms. Harriet L. Mascara, CEO
Kaltec Food Packaging, Inc.
36-40 Center St.
Port Jervis, NY 12771
Dear Ms. Mascara:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 36-40 Center Street Port Jervis, NY 12771 between the dates of February 12, 2018 to March 1, 2018 where you contract manufacture a variety of acidified foods. The inspection revealed serious violations of the regulations for acidified foods Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114).
Accordingly, 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. You can find the Act and the Acidified Food regulations through the link in FDA's home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations related to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 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 the mandatory requirements of 21 CFR Part 114.
We acknowledge your firm’s response dated March 15, 2018 submitted to the FDA Form-483, Inspectional Observations (FDA-483). We address the adequacy of specific corrective actions below. During our inspection, we observed the following significant deviations:
1.    As a commercial processor engaged in the thermal processing of acidified foods you must, no 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 level, 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). The FDA has no acidified scheduled process on file under your firm 's registration for products processed at your facility including Jersey Tomato Sauce Marinara, Sweet and Savory Black Bean Sauce, Southeast Asian Sweet Chili, Korean Gochujang, Veggie Bolognese, Chipotle Pizza Sauce, Caramel Pumpkin Butter, Roja (Red Sauce), Verde (Green Sauce) and Blanco (White Sauce).
Further, your firm could not provide evidence that the scheduled processes for the acidified food product Jersey Tomato Sauce Marinara that you manufacture was established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83.
Specifically, your firm is using a
(b)(4)
process to manufacturer Jersey Tomato Sauce Marinara that has not been evaluated by a Process Authority.
In your March 15, 2018, written response, you state that all scheduled processes will be filed with the FDA before product is produced. As of the date of this letter, you have not filed a scheduled process with the FDA for any products. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e a (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication " Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format'' available at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.
2.    Your firm has failed to manufacture your acidified food products in accordance with the scheduled process, as required by 21 CFR 114.80(a)(1).
a)  Specifically, the July 21, 2015 process letter for Sweet and Savory Black Bean Sauce product provided by a process authority identified the product as an acidified food and listed a fill temperature of
(b)(4)
°F. The process letter also provides the ingredients and weights of each ingredient to be used. During processing your firm is using ingredients that differ from the ingredients listed in the process letter as your firm no longer includes
(b)(4)
and
(b)(4)
which account for approximately
(b)(4)
percent of the total product weight in the process letter.
Although the July 21, 2015, process letter for Sweet and Savory Black Bean Sauce product lists a fill temperature of
(b)(4)
°F, your batch record template used during production states a temperature range of “
(b)(4)
”.
In addition, our investigators’ review of your production records from July 11, 2017; August 1, 2017; August 14, 2017; November 7, 2017 and February 1, 2018 revealed fill temperatures of below
(b)(4)
°F. Your firm failed to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which deviated from a scheduled process in accordance with 21 CFR 114.89.
Specifically:
The batch record for product manufactured on July, 11, 2017, packaged over several days into 1.5 oz. plastic cups, documents the following:
o  Cup Lot #
(b)(4)
, shows 10 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which were 146 and 150 °F.
o  Cup Lot #
(b)(4)
, shows 8 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which were 153 and 158°F.
o  Cup Lot #
(b)(4)
, shows 4 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 161.5 °F.
o  Cup Lot #
(b)(4)
, shows one fill temperature recorded at 165 °F.
o  Cup Lot #
(b)(4)
, shows 3 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 166 °F.
o  Cup Lot #
(b)(4)
, shows 8 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 170 °F.
The batch record for product manufactured on August 1, 2017, packaged over several days into 1.5 oz. plastic cups, documents the following:
o  Cup Lot #
(b)(4)
, shows 8 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 159 °F.
o  Cup Lot #
(b)(4)
, shows 2 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 191 °F. Additionally, 3 of
(b)(4)
fill temperatures were not recorded.
o  Cup Lot #
(b)(4)
, shows 5 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 172 °F.
o  Cup Lot #
(b)(4)
, shows 13 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 187 °F.
o  Cup Lot #
(b)(4)
, shows 12 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 180 °F.
o  Cup Lot #
(b)(4)
, shows 6 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 187 °F.
o  Cup Lot #
(b)(4)
, shows 7 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 190 °F.
o  Cup Lot #
(b)(4)
, shows 14 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 190 °F.
o  Cup Lot #
(b)(4)
, shows 10 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 190 °F.
The batch record for product manufactured on August 14, 2017, packaged over several days into 1.5 oz. plastic cups, documents the following:
o  Cup Lot #
(b)(4)
, shows 10 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 190 °F.
o  Cup Lot #
(b)(4)
, shows 9 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 190 °F.
o  Cup Lot #
(b)(4)
, shows 7 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, the lowest of which was 190 °F.
The batch record for product manufactured on November 7, 2017, packaged in 13 oz. glass jars, documents 3 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 189 °F.
The batch record for product manufactured on February 1, 2018, packaged in 5-gallon plastic pails, documents 3 of
(b)(4)
fill temperatures recorded below
(b)(4)
°F, of which the lowest was 190 °F.
b)  Specifically, the March 27, 2014, process letter for the Garlic Achaar product provided by a process authority identified the product as an acidified food and lists a critical factor of a maximum pH of
(b)(4)
. Although the March 27, 2014, process letter procedure states, “
(b)(4)
”, your processing steps used during production states, to check the pH of garlic to be sure it is, “
(b)(4)
.”
Additionally, your firm lacks processing records to show you are monitoring the process letter critical factor of pH in order to comply with 21 CFR 114.100(b).
Your written response dated March 15, 2018, is inadequate as you did not provide documentation of the corrective actions taken to address the affected product, processes, and records. Additionally, your response does not include how your firm intends to prevent reoccurrence of production records that include critical factors which differ from the process letters provided by a process authority. No revised production records were provided for review.
3.    Your firm’s operators are not under the supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction, as required by 21 CFR 108.25(f).
In your response dated March 15, 2018, you stated that you will be sending a management employee to a Better Process Control School approved by the Commissioner; however, we cannot evaluate the adequacy of your response because of lack of supporting documentation demonstrating satisfactory completion of instruction or registration and timeframe for completion. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.
4.    Your firm failed to maintain production records of examination of raw materials, packaging materials, finished products, and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels as required by 21 CFR 114.100(a). Specifically, records are not maintained documenting examination of raw materials and packaging materials.
Your written response dated March 15, 2018, is not adequate. Your response did not include copies of revised production records documenting these requirements were added to the records and implemented.
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 reinspection 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 do not believe that your products are in violation of the Act, 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: Scott R. Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Scott R. Izyk at 518-453-2314 x1012 or scott.izyk@fda.hhs.gov
.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
Content current as of:
06/19/2018