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  5. Paks Clothiers (dba) Aqua Pure Drinking Water - 09/30/2015
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WARNING LETTER

Paks Clothiers (dba) Aqua Pure Drinking Water


Recipient:
Paks Clothiers (dba) Aqua Pure Drinking Water


United States

Issuing Office:
Los Angeles District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506 
 
Telephone:      949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 30, 2015                                                                                                   
WL# 39-15
Mr. Chhaganlal Pithia, Co-Owner
Paks Clothiers, Inc., DBA Aqua Pure Drinking Water
12322 Dahlia Ave
El Monte, CA, 91732-3610
 
Dear Mr. Pithia:
 
We inspected your bottled water manufacturing facility located at 12322 Dahlia Ave, El Monte, CA, from April 6-13, 2015. Our inspection revealed serious violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129. These violations render the bottled water products processed at your facility 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), because they have been prepared, packed, or held under insanitary conditions where by it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and FDA's regulations through links on FDA's Internet homepage at www.fda.gov.
 
On May 4, 2015 we received a response letter Mr. Umesh C. Pithia, Operations Manager, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm at the conclusion of the inspection.  
 
We address the response below, in relation to each of the noted violations. Your significant violations were as follows:
  • You are required by 21 CFR 129.80(g)(1) to take and analyze at least one representative sample of each type of bottled water that you produce each week for coliforms. Any coliforms detected must be quantified. However only two samples were taken and analyzed between October 7, 2014 and April 13, 2015 and coliforms were detected but not quantified. You are further required to analyze samples for Escherichia coli (E. coli) if the samples yield any coliforms, however you did not. In your response you committed to testing for E. coli if coliforms are found, however you did not commit to quantifying coliforms as required by the rule. Finished products must meet the standards of microbiological quality for coliform specified in 21 CFR 165.110(b)(2), or be labeled as containing excessive bacteria, as indicated in 21 CFR 165.110(c). Bottled water products containing E. coli are adulterated (21 CFR 165.110(d)).
  • All bacteriological swabs and/or rinse counts from your multiuse containers must be free of coliform organisms in order to meet the requirements of 21 CFR 129.80(f). However, according to your tests, one five gallon container yielded coliforms. Between January 2013 and April 2015, you sampled your containers for rinse counts only on two occasions, 2/04/14 and 4/22/14. FDA recommends that you sample at least one every three months. In addition, you did not perform any bacteriological swab or rinse count tests on your closures during the subject period.
  • You are required to sample and test cleaning and sanitizing solutions as often as necessary to assure adequate performance in the cleaning and sanitizing operations and maintain records of these tests in order to comply with 21 CFR 129.80(c), however, you told our investigators that you do not monitor or keep records. In your response you identified tests you are conducting but you did not document that you are conducting these tests and keeping records.  
Your response to the FDA 483 addressed several issues; however you did not include documentation of the corrections you may have made.
 
Based on our review of the labels, your Aqua Pure brand bottled drinking water products in are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. 
  • Your Aqua Pure Drinking Water, 5 Gallon, bottled water product is misbranded within the meaning of section 403(g)(l) of the Act [21 U.S.C. § 343(g)(l)] in accordance with section 21 CFR 165.110(a)(3)(ii), in that the source water comes from a community water system, as defined in section 40 CFR 141.2, but the label fails to state "from a community water system" or alternatively, "from a municipal source", as appropriate, on the principal display panel or panels.
  • Your Aqua Pure Drinking Water, 5 Gallon, bottled water product is further misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] in accordance with section 21 CFR 101.5(a), in that the product fails to bear a label containing the place of business of the manufacturer, packer, or distributor.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. For example, the net quantity of contents statement for your Aqua Pure Drinking Water, 5 Gallon, bottled water product is not visible on the containers principal display panel in accordance with section 21 CFR 101.105(a).  This shall be expressed in terms of fluid measure, U.S. gallon and ounce.
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
CAPT Dan Cline, Acting Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
Foods: 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.
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
 
Sincerely,
/S/                                                                                   
Alonza E. Cruse, Director
Los Angeles District
 
Cc:
 
David M. Mazzera, Chief, Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413