- Food & Beverages
Mr. Pradip Patil
Quality Assurance Head and Partner
- Improva Herbal Products
Sai Kiran Complex
Rh C3 Sambhagi Nagar, Chinchwad
- Issuing Office:
- Center for Food Safety and Applied Nutrition
DEC 15, 2015
VIA EXPRESS DELIVERY
Mr. Pradip Patil, Quality Assurance Head and Partner
Mr. Gulab Walunj, Production Head and Partner
Sai Kiran Complex
Rh C3 Sambhagi Nagar, Chinchwad
Reference No: #484327
Dear Mr. Patil and Mr. Walunj:
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) firm, Improva Herbal Products, located at Murevasti, At post Kurali, Taluka Khed, District Pune, Pune, India 410510 on September 14-15, 2015. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm.
As a manufacturer of AF products intended for export to the United States, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing AF products. Regulations specific to the processing of AF products are described in 21 CFR Part 108 and 21 CFR Part 114. As outlined in these regulations, a commercial processor of AF products that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your AF products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). You can find the Act and the AF regulations through links in FDA’s home page at www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. We have the following concerns with regard to your AF products:
- Your firm failed to have scheduled processes 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 does not have scheduled processes established by a qualified individual for your acidified herbal juice products including, but not limited to, the following products: Ginger juice, Jamboo bij juice, Pomegranate juice, Arjunachhal juice, Tulsi juice, Wheat grass juice, Baeley juice, Haldi juice, Karela juice, and Nomi juice. The ingredients of these juice products have (b)(4) prior to (b)(4), which (b)(4); therefore, these herbal juices are considered AF products.
We acknowledge that your firm has registered with FDA as an AF processor and acquired a Food Canning Establishment (FCE) number; however, at this time, your firm has no scheduled processes on file for the AF products you process and ship to the U.S. as required by 21 CFR 108.25(c)(2).
- Your firm failed to have operators of processing and packaging systems under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner as required by 21 CFR 114.10. Specifically, your firm’s management has not attended the required training for the production of AF products shipped to the U.S.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and all applicable regulations, including the AF regulations (21 CFR Parts 108 and 114) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported AF products under section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the AF regulations (21 CFR Part 108 and 114) is Import Alert #99-37. This alert can be found on FDA’s web site at: www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm
Please send your reply to the U. S. Food and Drug Administration, Attention: Robyn R. Jones, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Jones via email at email@example.com.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
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