Mr. Santos Parmar
- Santos Agency Inc.
1188 Montague Street
San Leandro, CA 94577
- Issuing Office:
- San Francisco District Office
| || |
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
April 03, 2017
Mr. Santos Parmar, Manager
Santo Agency Inc.
1188 Montague Street
San Leandro, CA 94577
Dear Mr. Santos Parmar:
The U.S. Food and Drug Administration (FDA) inspected your bakery facility, located at 1188 Montague Street, San Leandro, CA, January 11-18, 2017. During the inspection, the FDA investigator documented serious violations of the current Good Manufacturing Practice (cGMP) Regulations, Part 110 [Title 21 CFR Part 110]. These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and these regulations through links in FDA’s home page at ww.fda.gov.
At the conclusion of the inspection, the Investigators issued your firm a FDA 483, Inspectional Observations, dated January 18, 2017. Your firm did not submit a written response to the observations documented on the FDA 483.
Your significant violations are;
1. Failure to ensure all rubbish and any offal shall be so conveyed, stored and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and a harborage or breeding place for pests and protect against contamination of f, food-contact surface, water supplies and ground surfaces as required by 21 CFR 110.37(f). Specifically,
- the main entrance of your firm has a dumpster that cannot be closed due to overflowing discarded food products, old pallets, empty soiled drums and old food containers within close proximity to the entrance of your facility which provides food and harborage for pests.
- There are numerous cartons of food products stored along the side of a freezer container on the premises outside your facility that may provide food and harborage for pests.
- The area above your repacking operation stores equipment, furniture, and building materials that are not used for production and may provide a breeding place for pests.
2. Failed to provide, where necessary, adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the main entrance to your facility has a roll up door that remains open during operations and allows access to your warehouse, repacking area and retail store. Doors opened to the outside provide access to pest.
3. Failure to clean all food-contact surfaces, including utensil and food contact surfaces of equipment, as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). Specifically, our investigator observed the use of oval shaped metal receptacles to hold bulk product for packaging into retail units. The bulk product is scooped into retail bags using metal scoops that are cleaned with a spray bottle of plain water and a rag. The receptacles are cleaned with a brush. There is no washing and sanitizing of equipment and utensil before or after production.
4. Failure to provide hand-washing facilities that are adequate and convenient and furnished with running water at a suitable temperature as required by 21 CFR 110.37(e)(2). Compliance with this requirement may be accomplished by providing: effective hand-cleaning and sanitizing preparations. The sink used for hand-washing has a bar of soap sitting inside a plastic storage container. In addition, as required by 21 CFR 110.37(e)(3), there is no sanitary towel service or suitable drying devices. Specifically, during the inspection your employees were observed washing their hands with a bar of soap sitting on the sink used for washing utensils. Bar soap has the potential to be a breeding ground for microbial activity. In addition, employees were observed drying their hands on a single cloth towel instead of using the towel dispenser which was empty and locked. You stated you could not open the towel dispenser to replenish. It is your responsibility to ensure proper hand-washing facilities are available for your employees.
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 the Current Good Manufacturing Practice regulation (21 CFR Part 110).
You should take prompt action to correct these violations and to establish procedures whereby such violations do no recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to seizure and injunction.
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 a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. 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 cost.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as labels, and photographs of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
Please send your reply to the Food and Drug Administration, Attention:
Lawton W. Lum,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 521298
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Darla R. Bracy
Acting District Director
Close Out Letter