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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Saint Thomas Catering Corporation 24-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration
466 Fernandez Juncos Avenue
Puerta De Tierra
San Juan, Puerto Rico 00901-3223

WARNING LETTER
SJN-01-21
Certified Mail
Return Receipt Requested

Mr. Jamal Dyer
General Manager
Saint Thomas Catering Corp.
Nisky Mail PMB-403
Saint Thomas, US Virgin Islands 00802

Dear Mr. Dyer:

On May 17-18, 2001 the Food and Drug Administration (FDA) conducted an inspection of your dairy plant located at Cyril E King International Airport, St. Thomas, US VI , 00802.

Our investigator found deficiencies which are considered violations of the FD&C Act and of Title 21 Code of Federal Regulations, Part 1250 (21 CFR 1250) and section 361 of the Public Service Act. Also review of the inspectional information found your milk product:

"REDUCED FAT MILK" to be misbranded within the meaning of section 403 (a)(1) of the Federal Food Drug and Cosmetic Act.

During the inspection, the following violations were noted:

  1. Your product labeled as "REDUCED FAT MILK GRADE A" is misbranded within the meaning of FD&C Act. The inspection revealed that you are introducing into interstate commerce via domestic flights of different interstate carriers such as airlines and cruise lines a pasteurized milk product produced by a milk plant not listed in the Interstate Milk Shipper List as a Grade A Milk Plant.

2. Your plant equipment and utensils are not properly maintained in such a manner to prevent cleaned utensils from becoming contaminated prior to being used.

  1. Utensils are not cleaned frequently enough to minimize contamination of food contact surfaces. Also the location of the dishwasher station and the traffic of incoming carts poses a risk that cleaned utensils can become contaminated.

Although a follow up inspection conducted appears to indicate that improvements have been made in the area of sanitation, it is your responsibility to mum that the milk products introduced into any interstate carrier arc obtained from a facility included in the IMS list as a Grade A Milk Plant. You should take prompt action to correct these deviations anti prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure, injunction and/or "Use Prohibited" classification for servicing of interstate carriers.

Please 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 being taken to prevent the recurrence of similar violations. If corrective actions can not be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

Your reply should be sent to the Food & Drug Administration, San Juan District Office, 466 Fernandez Juncos Ave., San Juan, PR 00901-3223, Attention: Carmelo Rosa, Acting Compliance Officer.

Sincerely,
Mildred R. Barber
District Director