Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Atlanta District Office

 

60 8th St NE
Atlanta, GA 30309
Telephone: 404-253-l 61
FAX: 404-253-1202

February 5, 2002
WARNING LETTER
VIA FEDERAL EXPRESS

Roy W. Sweat, President
Sweat Chiropractic Clinic
3274 Buckeye Rd NE
Atlanta, GA 30341

Ref. No. 02-ATL-19

Dear Mr Sweat:

An inspection of your facility conducted between December 11, 2001, and January 10, 2002, by Investigator Patricia F. Hudson. Our investigator found that in addition to being the specifications, you continue to perform quality assurance activities associated with your Atlas Orthogonal Adjusting Instrument. This product is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigator documented several significant deviations from the Quality System Regulation (QSR) as set forth in title 21 of the Code of Federal Regulations (21 CFR), Part 820. These deviations cause devices you distribute to be adulterated within the meaning of Section 501(h) of the Act. These deviations from the QSR include:

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. At the close of the inspection, the FDA 483 (Inspectional Observations) was issued to and discussed with you. The specific violations noted in this letter and in the FDA 483 are symptomatic of underlying problems in your firm's quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.

We acknowledge that corrections were promised to the investigator's observations during the inspection. No written response has been received to date. Of particular concern is that several of these observations were repeat violations that were discussed with you during our previous inspection conducted in 1996. These repeat deviations include failure to establish acceptance criteria, lack of control over changes in the device, and an inadequate complaint handling system. A copy of the FDA 483 issued at the conclusion of that inspection is enclosed.

Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory actions being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office in writing within fifteen (15) days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response to this letter should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.

Sincerely yours,
/s/
Ballard H. Graham
District Director

This page was posted on August 20, 2006.

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