Inspections, Compliance, Enforcement, and Criminal Investigations
Gulf Marine & Industrial Supplies, Inc. 27-Apr-05
Department of Health and Human Services
Public Health Service
New Orleans District
April 27, 2005
WARNING LETTER NO. 2005-NOL-19
John R. Cotsoradis, President
Gulf Marine & Industrial Supplies, Inc.
401 St. Joseph Street
New Orleans, Louisiana 70130
Dear Mr. Cotsoradis:
On January 25 - 26, 2005, a U.S. Food and Drug Administration (FDA) investigator inspected your vessel commissary and multiple food warehouse, located at 400 and 401 St. Joseph Street, New Orleans, Louisiana. The inspection was conducted to determine compliance with FDA's Current Good Manufacturing Practice regulations in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigator documented numerous insanitary conditions on Form FDA 483, Inspectional Observations, and Form FDA 2420, Food Service Establishment Inspection Report, which cause the ingredients and finished food products packed, and/or held at your facility, to become adulterated. The adulterated ingredients and finished food products are in violation of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 342(a)(3) and 342(a)(4)]. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov. Accordingly, your food products are adulterated since they consist in whole or in part of filthy substances and/or have been held under insanitary conditions whereby they may have become contaminated with filth. The deviations are as follows:
1. Failure to take effective measures to exclude pests from the facility and protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, evidence of rodent activity was observed in, on and near foods stored in your food storage facility. This evidence included dead and decomposing rodents, rodent excreta pellets, and rodent-gnawed food packaging. Also, rodent gnawing and general activity was observed on and within food product packaging, Specifically raw peanuts. Our FDA laboratory confirmed findings of rodent excreta pellets and gnawed packaging based on samples taken from your facility.
2 . Failure of the facility to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, the following possible vermin entryways were observed:
a. A street level window below the south loading dock with approximate 1" and '1/2" x 8" openings to the outdoors;
b. An uncapped, metal pipe on the outer west wall leading into the basement;
c . An east side street level window with screen mesh containing approximately 3/8" holes; and,
d. The south loading dock door remained open and unscreened during the inspection.
Additionally, our investigator documented your facility, including freezers and coolers, was overcrowded and disorganized, preventing him from inspecting the condition of most items warehoused. These conditions may also provide rodent harborage.
We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating. We are aware [redacted] [redacted] Warehouse Manager, voluntarily destroyed three, 50-pound sacks of whole, in-shell brazil nuts, and one, 50-pound sack of raw, whole, in-shell peanuts. Also, you made a verbal commitment corrective action would be made.
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific steps you are taking to correct the deviations, including an explanation of each step taken to prevent recurrence of similar violations. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter is not intended to be an all-inclusive list of the deviations at your facility. You are responsible for ensuring your facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR 110). You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention : Rebecca A. Asente, Compliance Officer, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. If you have questions regarding any issue in this letter, please contact Ms. Asente at (504) 253-4519.
Patricia K. Schafer
Acting District Director
New Orleans District