Inspections, Compliance, Enforcement, and Criminal Investigations
Delta Airlines, Inc. 4/13/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Atlanta District Office
April 13, 2011
Richard H. Anderson, CEO
Delta Airlines, Inc.
1030 Delta Blvd.
Atlanta, GA 30354
Dear Mr. Anderson:
On January 26 - February 2, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your Delta aircraft # (b)(4) which was located at 1775 Aviation Boulevard, Atlanta, Georgia, during the inspection. This inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your firm's compliance with applicable sections of the Interstate Conveyance Sanitation (ICS) regulations (21 Code of Federal Regulations (CFR) Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 U.S.C. § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant violations of 21 CFR Part 1250, under the PHS Act.
At the conclusion of the inspection, on February 2, 2011, our investigators issued a list of Inspectional Observations (FDA 483) to your firm. As documented on this form (copy enclosed), the following are the significant violations on your aircraft:
To comply with 21 CFR 1250.30(a), all places where food is prepared, served, or stored shall be constructed and maintained as to be clean and free from flies, rodents, and other vermin. However, our investigator observed the following evidence of rodent activity on your aircraft:
• Approximately 8-11 rodent excreta pellets above the right door panel in the forward galley (G1) where food is prepared by flight personnel;
• Approximately 10-20 rodent excreta pellets above the left door panel in the forward galley (G1) where food is prepared by flight personnel;
• Approximately 9-15 rodent excreta pellets on the right aisle of the aircraft over seats C3-C7;
• Rodent excreta pellets (too numerous to count) in three areas in ceiling panels located in the middle cross over galley G2, which is directly over places where food and drinks are stored in the aircraft; and
• Mammalian urine in six areas on ceiling panels located in the middle cross over galley G2.
Our laboratory analysis of samples collected during the inspection confirmed the presence of rodent excreta pellets and rodent urine stains in the aircraft.
We acknowledge your response, sent via email on January 28, 2011, outlining actions taken by Delta to exterminate the rodent infestation observed by our investigator on aircraft # (b)(4) However, the corrective actions identified in these responses do not include actions your firm is taking to prevent future rodent infestations. We believe a recurrence is likely without adequate preventive measures in place.
You should take prompt action to correct the violations addressed in this letter. This letter is not intended to be an all-inclusive list of violations that may exist at your facility. You are responsible for ensuring that your firm operates in compliance with the requirements of the PHS Act, the Federal Food, Drug, and Cosmetic Act, and applicable regulations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have already taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to Derek C. Price, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, GA 30309. If you have any questions about the content of this letter, please contact Mr. Price at 404-253-2277.
Atlanta District Office