• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

CVS/Pharmacy #6648 2/28/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229 

 

WARNING LETTER
 FEB 28, 2013
VIA UPS
 
CVS/Pharmacy #6648
Attn: Site Manager
655 South US Highway 31
Greenwood, IN 46142
 
Re: FDA Warning Letter Regarding Tobacco Retailer Inspection Violations
       Reference Number: 13IN001568
 
Dear Sir or Madam:
 
This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that CVS/Pharmacy #6648 was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.
 
On February 9, 2013, an inspector representing the FDA completed an inspection of the establishment, located at 655 South US Highway 31, Greenwood, IN 46142. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor and failed to check identification to verify purchaser’s age.    
 
This inspection revealed that the establishment sells, distributes, advertises, and/or promotes cigarettes, cigarette tobacco, and/or smokeless tobacco, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violations observed during the February 9, 2013, inspection include the following:
 

1. A minor was able to buy Pall Mall Blue 100’s cigarettes on February 9, 2013, at approximately 2:03 PM in the establishment.

 
A retailer must NOT sell cigarettes, cigarette tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(a).
    

2. No one in the establishment checked the minor’s identification before the sale of Pall Mall Blue 100’s cigarettes on February 9, 2013, at approximately 2:03 PM.

 
A retailer MUST check a photographic identification that includes a date of birth for any person under the age of 27 who attempts to purchase cigarettes, cigarette tobacco, and/or smokeless tobacco. Failure to do so violates 21 C.F.R. § 1140.14(b)(1).
 
 
The listed violations cause your cigarettes to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c). 
 
You should immediately correct the violations listed above. Failure to correct the violations may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.
 
The violations indicated in this letter may not be a complete list of violations at the establishment. The establishment must comply with all the applicable laws and regulations. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts.    
 
You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violations and preventing future violations. Include a telephone number and address. Note your reference number of 13IN001568 in your response and mail it to:
 
SP-WL Response
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
 
If you have any questions, contact Carisa Bergen at (301) 796-2990 or via email at Carisa.Bergen@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.
 
Sincerely,
/s/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
Return to Tobacco Retailer Warning Letters Main Page