Bharat Bazar, Inc. 7/13/15
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
July 13, 2015
Veena Birla, Vice President/Secretary
Bharat Bazaar, Inc.
Union City, CA 94587
Dear Ms. Birla:
During April 14 through 22, 2015, United States Food and Drug Administration (FDA) investigators inspected your warehouse and repacking facility located at 49127 Milmont Dr., Fremont, CA. This inspection found your firm warehouses and repacks various foodstuffs including flour, moong beans and cumin seeds. The inspection determined you have significant deviations from the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the food products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Act, [21 United States Code (USC) 342(a)(4)] because 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 the LACF regulations through links in FDA’s website at www.fda.gov.
Our investigators provided you with a Form FDA 483, Inspectional Observations, at the close of the inspection on April 14, 2015. A copy of the Form FDA 483 is enclosed for your reference. We acknowledge Sandeep Birla’s written response to the FDA-483 and address the response under each item below. Violations revealed during the inspection include, but are not limited to, the following:
1) You must take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pest, in accordance with 21 CFR 110.35(c). Specifically, rodent excreta pellets (REPs), confirmed by FDA analysis, and apparent rodent gnaw holes were observed in the following locations within your manufacturing facility:
a) approximately 499 REPs were observed on or inside 35 woven bags of flour located in the packaging area.
b) approximately 87 REPs on the floors along the Northeast wall (15 REPs), East wall (5 REPs), Southeast wall (27 REPs), and South wall ( 40 REPs) of the Repacking area.
c) approximately 37 REPs on the office bathroom floor (7 REPs), and wood shelves outside the office bathroom (30 REPs).
d) approximately 293 REPs on the floors along the Northeast wall (9 REPs), East wall (150 REPs), South wall (50 REPs), Southwest wall (75REPs), and West wall (9 REPs) of the Packaged area.
e) approximately 42 REPs on the floors underneath pallets (32 REPs) and between gray bins (10 REPs) in the Packaged area.
f) approximately 5 REPs under a work table (4 REPs) and in between ready-to-use recycled cardboard boxes (1 REP) next to the repacking machine in the Repacking area.
We acknowledge that you destroyed the 35 bags referenced in above. We will verify your corrective actions regarding pest controls during our next inspection.
2) You must clean and sanitize equipment in manner that protects against contamination of food, in accordance with 21 CFR 110.35(a). Specifically, the vacuum cleaner identified by your vice president/secretary for use in cleaning the flour repacking machine was observed being used to clean apparent REPs from the floor and wood shelves.
Your response fails to include any cleaning/sanitizing of the vacuum cleaner.
3) You must properly store equipment, remove litter, and remove waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, in accordance with 21 CFR 110.20(a)(1). Specifically, there are grass and weeds approximately 1-2 feet in height growing next to the West wall along the ground outside your facility, unclean recycled cardboard boxes with leftover produce and food residues in the parking lot and inside the repacking area next to repacking machine, and, in the repacking area, an unused flour repacking machine that has not been used for a few months had not been cleaned and contained flour.
Your response fails to address the actions taken to prevent recurrence of the violations. For example, your response states that a gardener has removed the vegetation around the facility but does not include any actions to address maintaining are free of overgrown vegetation.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is also your responsibility to assure not only the current objectionable conditions are corrected, but appropriate policies and procedures are implemented to prevent recurrence of the problems. You should take prompt action to correct these violations. Failure to make corrections could result in regulatory action without further notice. Possible actions include, but are not limited to, seizure and injunction.
You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation, including an explanation of each step taken to prevent the recurrence of a similar violation. At the conclusion of the inspection, we noted you promised to correct the objectionable conditions noted on the Form FDA 483. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. If you cannot complete all corrective action before you respond, we expect that you will explain the reason for your delay and state when you will correct remaining deficiencies.
Section 743 of the Act, [21 USC 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 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 USC 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 re-inspection-related costs.
Please send your reply to the attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference CMS # 84953 in your response.
If you have questions, concerning the contents of this letter, you may contact Mr. Campbell at (510) 337-6861.
Kathleen M. Lewis, J.D.
San Francisco District