Inspections, Compliance, Enforcement, and Criminal Investigations
Millner Trading Company, Inc. 30-Aug-07
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 30, 2007
Mr. Giel N. Millner
Millner Trading Company, Inc.
18 W. Goepp Street
Bethlehem, PA 18044
Dear Mr. Millner:
On March 27 and April 2, 2007, we inspected your acidified food manufacturing plant located at the above address. We found that you have serious deviations from the Acidified Food regulations (21 CFR Parts 108 and 114). 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 in 21 CFR Part 114. Acidified foods processed in violation of certain requirements in 21 CFR Part 114 are considered to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), because they have been prepared, packed or held under insanitary conditions whereby they may have become injurious to health. You can find the Act and the Acidified Food regulations through links in the Food and Drug Administration (FDA) home page at http://www.fda.gov.
During the inspection, our investigator documented deviations from the Act and the above-mentioned regulations relating to the processing of lupini beans. These deviations cause this acidified food product to be adulterated under Section 402(a)(4) of the Act, in that the lupini beans have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
The significant deviations are as follows:
1. Your firm failed, not later than 60 days after registration and before packing any new product, to provide the FDA with information on the scheduled process including as necessary, conditions for heat processing and control of pH, salt, sugar, and/or preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Scheduled process information for acidified foods must be submitted on Form FDA 2541a (food canning establishment process filing form for all methods except aseptic) [21 CFR 108.25(c)(2)].
2. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods [21 CFR114.83].
Inspection of your firm revealed that you did not establish a scheduled process or have one established for you to manufacture acidified lupini beans. You could not provide our investigator with information that the manufacturing process for lupini beans you use would insure a pH value of 4.6 or less. Currently, the product [redacted] and there is no assurance that the product would not support the growth of microorganisms of public health significance.
3. Your firm failed to employ appropriate quality control procedures to ensure that finished foods do not present a health hazard. Specifically, your firm failed to measure the finished equilibrium pH by a potentiometric method, or exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6 [21 CFR 114.80(a)(2)].
Inspection of your firm revealed that your firm only monitors the [redacted], containing previously cooked lupini beans. Your firm does not measure and record final equilibrium pH of lupini beans.
Finished equilibrium pH for your firm's lupini beans is a critical factor that must be monitored by taking pH measurements after equilibrium is reached. As a result of our inspection of your firm on March 27 and April 2, 2007, FDA collected a sample (FDA sample number 416868) of your firm's [redacted] brand Lupini Beans, and it was determined that the pH ranged from 4.0 to 4.2. When the finished equilibrium pH is greater than 4.0, it must be determined by a potentiometric method (pH meter).
We note that you have a long history of failing to adhere to the requirements for registration and process filing, as required by 21 CFR 108.25. Review of FDA records reveals that A. Millner Company, Inc., located at [redacted] Street, New York, New York 10013, registered and filed as an acidified food manufacturing on January 5, 1981. In response, FDA assigned the processing establishment located at that address, Food Canning Establishment (FCE) number [redacted]. Subsequently, your firm moved its acidified food processing establishment from its New York location to [redacted] Street, Easton, Pennsylvania 18044. Commercial processors duly registered under 21 CFR 108.25(c)(1) are required to notify the FDA not later than 90 days after ceasing or discontinuing the manufacturing, processing or packing of acidified foods. There is no record that your firm ever notified FDA that it had discontinued acidified food processing operations at the New York address. On July 1, 1993, FDA files were annotated to indicate that FCE [redacted] was out of business. Within 10 days of when your firm began the manufacturing, processing or packing of acidified food at [redacted] Street, Easton, Pennsylvania, your firm was required by 21 CFR108.25(c)(1) to register and file information pertaining to its acidified food manufacturing, processing, or packing establishment. Your firm was reminded of the requirement in a letter from this office dated May 31, 1995. Review of FDA records revealed that your firm does not appear to have notified FDA that it was discontinuing the manufacturing, processing and packing of acidified foods at the [redacted] Easton, Pennsylvania location.
Further, review of FDA records reveals that A. Millner Company, Division of Millner Trading Company, located at [redacted] Street, Bethlehem, Pennsylvania 18044, registered as an acidified food manufacturer on July 22, 2003. The registration of your firm may have been submitted in response to a FDA inspection conducted at your Bethlehem, Pennsylvania, location during March, 2003. In response, FDA assigned the processing establishment located at that address, FCE number [redacted]. Not later than 60 days after registration and before packing any new product, a commercial processor is required to provide FDA with the scheduled processes for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). As previously noted, you have failed to file the scheduled process for lupini beans manufactured at the Bethlehem, Pennsylvania location.
We are enclosing several copies of Form FDA 2541 a (food canning establishment process filing form) for your use.
You should take prompt action to correct these deviations. Failure to do so may result in regulatory action without further notice. These actions include seizure or issuance of an order of need for a Temporary Emergency Permit. Please notify this office in writing within fifteen (15)working days from your receipt of this letter specifying the steps you have taken to correct the noted deviations and the time frame within which the corrections will be completed. Corrective actions should also indicate the person responsible for effecting correction, and include any supporting documentation indicating correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all of the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Emergency Permit Control regulations (21 CFR Part 108), the Acidified Food regulations (21 CFR Part 114), and the Good Manufacturing Practice regulations for foods (21 CFR 110).
Your response should be sent to Rhonda J. Walley, Compliance Officer, at the address noted in the letterhead.
Thomas D. Gardine
Form FDA 483 dated April 2, 2007
Form FDA 2541a (food canning establishment process filing form)
cc: Pennsylvania State Department of Agriculture
Bureau of Foods & Chemistry
2301 North Cameron Street
Harrisburg, PA 17120-9408
Attn: Sheri Morris