Inspections, Compliance, Enforcement, and Criminal Investigations
American Eagle/Executive Airlines, Inc. 12/7/05
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
San Juan District Office
December 7, 2005
RETURN RECEIPT REQUESTED
Mr. Gary Ellmer
American Eagle/Executive Airlines, Inc.
P.O. Box 38082 Airport Station
San Juan, PR 00937-0082
Dear Mr. Ellmer:
On August 8-12, 2005, FDA conducted an inspection of your airline's commissary servicing facility, including your catering point operation. We found that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) and of sections 402(a)(3) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 342(a)(3) and (a)(4). Accordingly, your ice is adulterated in that it is unfit for food. Your ice and other food products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the CGMP regulation through links in FDA's home page at www.fda.gov.
Your most serious deviations were as follows:
1. FDA observed a (b)(4) encrusted in ice that was intended to be served with drinks during flights.
2. You must provide, where necessary, adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, FDA observed a gap between the bottom of the entry door located at the East side wall of the commissary and the floor that may permit the entry of pests and other contamination.
3. All food contact surfaces, including food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against contamination of food, to. comply with 21 CFR
110.35(d). Further, all plant equipment must be properly maintained, to comply with 21 CFR 110.40. However, FDA observed the following:
• pieces of metal screws, nuts and washers on the floor of one of the ice storage bins in your commissary,
• a door located at the top of an ice making machine that did not close properly,
• a broken rubber gasket on a coffee maker,
• mold-like stains on a rubber gasket on the freezer used to hold beers, and
• a broken plastic frame around the doors of the two storage bins used for packed ice.
We acknowledge that at the closing of the inspection on August 12, 2005, some deficiencies were corrected by your firm. However, there are still significant deviations discussed above that need to be corrected by your firm.
Please advise us in writing within fifteen (15) working days of the receipt of this letter of the actions you have taken to address the deficiencies. Your response should include an explanation of each step being taken to correct the deficiencies and prevent their recurrence. You should also include copies of any available documentation demonstrating that corrections have been made. Failure to promptly correct these deviations may result in regulatory action without further notice. Such action may include seizure and/or injunction.
Your response should be directed to: Food and Drug Administration, Attention: Miguel A. Hernandez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, P.R. 00901-3223. If you have questions regarding any issue in this letter, please contact Mr. Hernandez at 787-474-9519.
David Gan, M.D., Dr. PH, MPH
Acting District Director
San Juan District