Inspections, Compliance, Enforcement, and Criminal Investigations
San Diego Cold Storage 6/10/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Southwest Import District|
4040 North Central XPY
Dallas, Texas 75204
Telephone: (214) 253-5200
FAX: (214) 253-5316
June 10, 2013
RETURN RECEIPT REQUESTED
Mr. Frank E. Plant III President and Owner
c/o Harborside Refrigerated Services
802 Terminal Street
San Diego, CA 92101
Dear Mr. Plant III,
The Food and Drug Administration (FDA) conducted an inspection at your public cold storage warehouse, San Diego Cold Storage, located at 8671 Lonestar Road, San Diego, CA 92154 on April 15-17, 2013. Our findings revealed and sample analyses confirmed the products held at the facility were adulterated within the meaning of Section 402(a)(3), [21 U.S.C. 342 (a)(3)] in that they were found to contain rodent filth, and Section 402(a)(4), [21 U.S.C. 342 (a)(4)] because the products have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may been rendered injurious to health. You may find the Act and the regulations through links in the FDA's Internet homepage at www.fda.gov.
At the conclusion of the inspection, investigators provided you with Form FDA-483, which delineated a number of gross insanitary conditions present in your warehouse at the time of the inspection. Among the insanitary conditions we observed:
1) Large and small rodent excreta pellets on boxes, on and within stored raw papaya, on the floor, in the floor comers, on top of the bar rails and alongside of pallets of stored papaya product in (b)(4). We note that there are gaps under a door leading outside, large enough to allow in ingress of pests.
2) There was dirt and dust on ceilings and fan guards in front of cooling units in cooler (b)(4), an accumulation of dirt, dust, cob webs and debris in the comers on the floor and throughout all storage areas within the facility.
3) Water was dripping from a clear plastic window panel in the ceiling directly onto stored papaya in the dry good storage area. There were two additional leaks from ceiling panels in (b)(4).
These findings demonstrate that you are not adequately cleaning or controlling pests in your facility.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations.
Your action to destroy all product stored at the facility that was subject to the State embargo has been noted. However, we recommend that you take additional measures to prevent the introduction of pests, such as rodents, into your facility, which may cause the food articles stored in your facility to be adulterated. Failure to promptly correct these deviations may result in regulatory actions, including seizure and/or injunction without further notice.
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining deviations will be corrected.
Please send your reply to U.S. Food and Drug Administration, Attention: Joseph Brady, Compliance Officer, at the following address: 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have questions regarding the issues in this letter, please contact Joseph Brady, CO at 619-941-3678 Ext. 3697.
Stacy M. Below
Acting District Director