- Constantine Poulos and Company dba International Foods, Inc.
- Issuing Office:
- New England District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 491489
UNITED PARCEL SERVICE
April 21, 2016
Mr. Constantine Poulos, Owner
Constantine Poulos and Company dba International Foods
200 Main Street
Burlington, VT 05401
Dear Mr. Poulos,
On February 1, 8, & 11, 2016, the U.S. Food & Drug Administration (FDA) conducted an inspection of your acidified food (AF) processing facility located at 220 Pioneer Drive, Williston, VT where you manufacture acidified pepperoncini products. 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 United States Code
(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 link in FDA’s home page at http://www.fda.gov
As an AF processor, you are required to comply with the Act and the federal regulations relating 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 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 AF products 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.
During our inspection, we noted the following serious violations:
1. As a commercial processor engaged in the processing of acidified foods, you must, not 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). Specifically, your firm currently has no scheduled process on file with FDA for the acidified pepperoncini products you repack into one gallon size containers. We acknowledge your firm’s submission of a scheduled process on October 23, 2015 for your firm’s “(b)(4)” product; however, the scheduled process was never considered filed due to missing data as identified in the FDA correspondence sent to you dated November 12, 2015. At this time, we have not received any updated scheduled process information.
2. Your firm failed to manufacture acidified food in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, during our inspection we observed that you are not following the scheduled process established for you by (b)(4), for the acidified pepperoncini products you repack into one gallon size containers. The scheduled process established for you by (b)(4) requires you to repack your pepperoncini in (b)(4). During our inspection we observed that your firm drains bulk pepperoncini, repacks the drained pepperoncini by hand into one gallon plastic jars, and then you top each jar with a new water and vinegar solution. In addition, your firm failed to adhere to the following process filing requirements: (b)(4). Our investigator also observed the temperature of your firm’s warehouse to be approximately 57°F, rather than the required (b)(4).
3. Your firm failed to exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). Specifically, your firm does not routinely monitor or record the finished equilibrium pH of the acidified products you manufacture to ensure finished product pH does not exceed 4.6 (i.e., the required value under the regulation). More importantly, because you are producing a cold fill/hold product, adhering to your maximum equilibrium pH is critical. In accordance with 21 CFR 114.90(b), colorimetric methods for pH measurement are permitted for products that have a pH of 4.0 or lower; however, you must maintain records of monitoring the equilibrium pH for each batch as required by 21 CFR 114.100(b).
4. You must prepare, review and retain at a reasonably accessible location for three years all records specified in 21 CFR 114, as required by 21 CFR 108.25(g). Specifically, during our inspection we found your firm does not create production records or any other processing records to include records of deviations in processing. Further, we found that your firm does not maintain records of the examination of raw materials, packaging materials, and finished products.
5. You must mark each container with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period, as required by 21 CFR 114.80(b). Specifically, you do not place any codes that specify the establishment where the product was packed, product contained therein, year, date, and packing period on your pepperoncini products packaged in one gallon hermetically sealed plastic jars. We found you were not able to identify lots of ingredient pepperoncini packed into specific finished product lots and you were not able to identify the packing period for any of your ingredient or finished product lots.
6. 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, our inspection found that you do not conduct any container testing or perform any visual examinations of your product containers to assess the integrity of the seal of the container lids prior to releasing for distribution your acidified pepperoncini product. Because your containers are hand sealed and may be prone to leakage, we recommend consulting with a competent authority on your container and closure system since your scheduled process includes (b)(4).
7. Your firm failed to prepare and maintain in files, plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying the Food and Drug Administration of any recalls; and for implementing recall programs, as required by 21 CFR 108.25(e). Specifically, your firm’s “International Foods Recall Policy” included in your firm’s March 1, 2016 response to the FDA-483 does not include specific recall procedures meeting these requirements. Further, during our inspection, your firm agreed to conduct a voluntary recall of your acidified pepperoncini products for undeclared sulfites and the recall notification to your customers was delayed due partly to your lack of current procedures.
8. Your firm failed to package foods under conditions and controls necessary to minimize contamination, as required by 110.80(b)(2).
Specifically, during our inspection we found:
- During packaging of olives, your staff placed an insanitary drum of olives on the drain table. Your staff then rinsed and rubbed the drum with a chlorine solution such that the filth from the drum rinsed directly onto the drain table. As the contents of the drum were emptied, the drum was moved in such a manner that olives contacted the surface of the table where the drum had previously been resting.
- During packaging of pepperoncini, your staff collected brine from pepperoncini dumped on the drain table into a 5 gallon bucket by attaching a hose from the drain table to the bucket. The hose was observed to be in an insanitary condition and was submerged in the 5 gallon bucket of collected brine. You stated that the brine would be poured back into the holding container to be added to your finished product pepperoncini.
- We observed apparent spilled brine solution on the warehouse floor.
- Your repacking area is not separated from your warehouse/storage area. Dust and particulates may become airborne with the movement of materials via the forklift
- Exposed food is in close proximity to forklift exhaust
9. Your firm lacks adequate hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands, as required by 110.37(e)(1).
Specifically, we observed you do not have a hand washing sink in your processing area for your employees to use as they pack pepperoncini and olives.
10. Your firm failed to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1). Specifically, our inspection found waste, to include filled pepperoncini containers, to be stored outside of your facility, in close proximity to the rear bay doors. The waste also included apparent building materials leaning against the exterior wall of your processing facility.
We acknowledge receipt of your response dated March 1, 2016; however your response cannot be evaluated because of a lack of supporting documentation that demonstrates that you have corrected all of the above violations.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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 re-inspection 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.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled processes have been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725, extension 1109.
LCDR, Matthew R. Palo
Acting District Director
New England District