Mr. Pankaj Agarwal
- Haldiram Snacks Pvt. Ltd.
Haldiram House, Plot No. 145/146
Old Pardi Naka, Bhandara Road
- Issuing Office:
- Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740
JUL 6, 2017
VIA EXPRESS DELIVERY
Mr. Pankaj Agarwal, Managing Director
Haldiram Snacks Pvt. Ltd.
Haldiram Foods International Pvt. Ltd.,
Haldiram House, Plot No. 145/146
Old Pardi Naka, Bhandara Road, Nagpur - 440 008 (M.S.) India
Dear Mr. Agarwal:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low acid canned food (LACF) facility, Haldiram Snacks Pvt. Ltd., Haldiram Foods International Pvt. Ltd., A 2-4, Sector 65, Noida, Uttar Pradesh, 201307, India on April 18 & 19, 2017. The inspection revealed serious violations of the Emergency Permit Control regulation [Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)] and the Low Acid Canned Foods (LACF) regulation (21 CFR 113). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge your written response dated May 1, 2017, to the observations made during the FDA inspection of your facility. Our review of your response determined that your firm has not adequately addressed all the deviations related to your LACF products.
In accordance with 21 CFR 108 and 21 CFR 113, failure of a LACF facility to operate in accordance with the requirements of 21 CFR 108 and 21 CFR 113, renders the LACF products 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)]. Accordingly, your LACF products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, the failure of an LACF facility to comply with all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 113 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 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a 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. You may find the Act, 21 CFR 108 and 21 CFR 113 through links in FDA's home page at www.fda.gov.
We note the following significant deviations:
1. A critical factor specified in the scheduled process you filed for processing your low-acid food in hermetically sealed containers was not measured and recorded at intervals of sufficient frequency to ensure that the critical factor was within the limits specified in the filed scheduled process as required by 21 CFR 113.40(j). Specifically, our investigator noted that process establishment data provided by your process authority, DWC FoodTech Pty Ltd, Melbourne, Australia in December 2016, for your Dal Makhni product packed in (b)(4) x (b)(4) pouches included viscosity as a critical factor, based on your process authority’s final heat penetration study and lethality report. The filed scheduled process submitted to FDA identified, the critical factor associated with the manufacturing process as:
a. Viscosity (Bostwick at (b)(4) in (b)(4) seconds) - (b)(4) cm.
However, our inspection revealed that you did not monitor the viscosity for your Dal Makhni product packed in (b)(4) x (b)(4) pouches that were manufactured on February 2, 2017, Lot code (b)(4).
We acknowledge your May 1, 2017, emailed response which included monitoring records for processing your Dal Makhani product. However, the processing information states viscosity of the product will be measured at (b)(4) in (b)(4) seconds - (b)(4) cm and your firm’s monitoring record shows viscosity at (b)(4)cm and (b)(4)cm, but does not include the critical factor for time ((b)(4) seconds) and temperature ((b)(4)) in the monitoring record.
2. Your firm failed to process each low-acid canned food in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i). Specifically, our investigator noted that process establishment data provided by your process authority DWC FoodTech Pty Ltd, Melbourne, Australia in December 2016 for your Dal Makhni product in (b)(4) x (b)(4) pouches was submitted to the FDA based on your process authority’s final heat penetration study and lethality report. The scheduled process submitted to FDA identified, in part, the following as critical factors associated with the manufacturing process:
a. Viscosity (Bostwick at (b)(4) in (b)(4) seconds) - (b)(4) cm
b. Minimum initial product temperature - (b)(4).
Our investigator noted that the viscosity for Dal Makhni product packed in (b)(4) x (b)(4) pouches manufactured on March 3, 2017 was (b)(4) cm, (b)(4) cm, and (b)(4) cm, consecutively which are less than the filed process of 17.0 cm.
Our investigator also noted that the minimum initial product temperature for Dal Makhni product packed in (b)(4) x (b)(4) pouches manufactured on April 5, 2017 was (b)(4), which is less than the filed process of (b)(4).
Additionally, process establishment data provided by DWC FoodTech Pty Ltd, Melbourne, Australia in December 2016, for your Rajma Raseela product packed in (b)(4) x (b)(4) pouches was submitted to the FDA based on your process authority’s final heat penetration study and lethality report. The filed scheduled process identified, in part, minimum initial product temperature of (b)(4) as a critical factor associated with the manufacturing process. The initial product temperature taken for Rajma Raseela product packed in (b)(4) x (b)(4) pouches entering the retort on April 19, 2017 was (b)(4), which is less than the filed process of (b)(4). This was recorded on the processing record as (b)(4) by the operator.
We acknowledge your May 1, 2017, emailed response which included Summary of Critical Factors of Production procedure from your process authority. The response states that laminated copies of the process are placed at each testing location so operators are aware of out of specifications to ensure that corrective action can be taken at the point and flagged on the proper documentation. DWC Food Tech Pty Ltd, Melbourne, Australia has been engaged to review and sign off on the process deviations. Your response stated the observations for the process of Dal Makhani 300g (10.6 oz.) in (b)(4) x (b)(4) pouches manufactured on March 3, 2017 has been forwarded to DWC and is under review. Lastly, training will be provided to operators to ensure that any out of limit specifications are flagged and corrective actions taken and documented. However, adequate corrective action documentation was not provided for FDA review.
Your firm failed to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control as required by 21 CFR 113.89. Specifically, review of processing records associated with the process deviations as noted above were not acknowledged and corrective actions were not taken.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lot of product produced over at least five days. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Responding in English will help to assist us in our review of your documentation.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF 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 LACF regulations (21 CFR 108 and 113) is Import Alert 99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Due to Inadequate Process Control. This alert can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html
In addition to the above deviations, please be aware that the calibration of the thermometer used to monitor your pasteurization should be repeated as necessary. We acknowledge your response included records demonstrating your firm’s calibration of the thermometer used to monitor the temperature of the pasteurizer; however, we note that calibration should occur as frequent as necessary to adequately maintain the equipment in accordance with current Good Manufacturing Practices (21 CFR 110).
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the 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 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 foreign facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at email@example.com. Please reference case # 525906 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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