Gourmail, Inc. dba Jyoti Natural Foods 5/22/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
May 22, 2014
DELIVERED VIA UNITED PARCEL SERVICE
Vijay P. Gupta, CEO/Owner
Gourmail, Inc., dba Jyoti Natural Foods
300 Elmwood Avenue
Sharon Hill, PA 19079
Dear Mr. Gupta:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 300 Elmwood Avenue, Sharon Hill, PA, on April 30, 2014 through May 1, 2014. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility 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 were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov
Our inspection of your facility revealed the following CGMP violations:
1. Your firm is not constructed in such a manner so that ceilings may be adequately cleaned and kept in good repair; and that drip or condensate from fixtures does not contaminate food, food-contact surfaces, and food-packaging material, as required by 21 CFR 110.20(b)(4) (FDA-483 Observation #1 and #2). Specifically, on April 30, 2014, our investigators observed the following:
a. Water originating from the roof of your firm was observed dripping from an exhaust vent in the ready-to-eat (RTE) airline meal production area. The water was dripping onto a kettle lid that contained a one (1) inch gap that runs approximately one-third the length of the kettle lid; thus, failed to preclude the liquid from splashing into the kettle. The kettle contained in-process (b)(4) Lot #(b)(4), which is a component of a RTE airline meal identified by product #(b)(4) and batch #(b)(4). We acknowledge that on May 1, 2014 you informed our investigator that this product was voluntarily destroyed and you showed him that a tarp had been positioned below the exhaust vent, but above kettles #1 through #4 to block the dripping rain water from reaching the kettles. This measure is not an adequate corrective action to prevent contamination of your products. Further, you were unable to provide our investigator with a time frame for the repair of this serious deviation, and as of the date of this letter, we have not received any correspondence from your firm to indicate that the roof has been repaired to prevent any future adulteration of your products.
b. Ceiling tiles, directly above food preparation areas, were observed to be stained by previous roof leakage. Further, these ceiling tiles are textured and did not appear to be composed of an easily cleanable material to preclude the contamination of food. During the inspection, you informed our investigators that you would replace these tiles. However, as of the date of this letter we have not received any correspondence from your firm to indicate that the ceiling tiles have been replaced with tiles that are easily cleanable.
2. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source as required by 21 CFR 110.80 (FDA-483 Observation #3). Specifically, on April 30, 2014, our investigators observed a hose adjacent to kettle #2, in the RTE airline meal production area, laying nozzle down on a movable step that workers stood on to access product inside the cooking kettles. Further, your firm’s Business Manager informed our investigators that water from this hose is added directly to in-process product. The movable step that the hose nozzle was laying on had visible filth on it, from prior use.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
We request that you respond to this office in writing within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the deviations, to include documentation of those corrections. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Your response of corrective actions should be directed to Ms. Lynn S. Bonner, Compliance Officer, U.S. Food and Drug Administration, Philadelphia District Office, 900 US Customhouse, 2nd
& Chestnut Streets, Philadelphia, PA 19106. If you have any questions, please do not hesitate to contact Ms. Bonner at (215) 717-3074, or you can email her at email@example.com
Anne E. Johnson
Acting District Director
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408