Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Science Products, Inc. 07-Jul-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
WARNING LETTER CIN-05-26433-14
July 7, 2005
Gary J . Smith, President
Medical Science Products, Inc.
517 Elm Ridge Avenue
Canal Fulton, OH 44614-9369
Dear Mr. Smith:
An inspection of your medical device manufacturing firm located in Canal Fulton, OH conducted by our investigator from June 7-10, 2005, revealed that the devices manufactured at that facility, class II disposable and re-useable electrodes, are adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code 351(h)], in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The deviations from the QSR include, but are not limited to, the following:
Failure to establish procedures for implementing corrective and preventive actions. [21 CFR 820.100 (a)]
Failure to implement procedures to ensure that all oral complaints are documented upon receipt. For example, you told the investigator that sometimes you send replacement products to customers if they complain that the electrodes are not sticking. You do not document this as a complaint or perform an investigation as to the root cause of the problem. [21 CFR 820.198]
Your device history records do not always accurately reconcile the number of devices tested versus the number of devices that passed. For example, five out of the 17 device history records that were reviewed had a discrepancy between the number of tested devices versus the number of passing devices. [21 CFR 820.184]
lncoming products are not always adequately inspected or tested to verify conformance to specifications. For example, 2 out of the 5 inspection records for Poly II (a component in your electrodes) showed values that were out of your acceptance range. [21 CFR 820.80]
You have not established any procedures for the handling of non-conforming products. [21 CFR 820.90]
You have not defined or implemented any procedures for design controls. [21 CFR 820.30]
You have not established any procedures for management review. [21 CFR 820.20
You have not established any document control procedures. [21 CFR 820.40]
The inspection also revealed that your firm failed to establish and maintain written Medical Device Reporting (MDR) procedures as required by 21 CFR 803. This causes the devices you manufacture to be misbranded under section 502(t)(2) of the Act [21 USC 352(t)(2)].
The deficiencies listed above are serious violations of the law. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Neither this letter nor the FDA-483 that was issued at the conclusion of the inspection is intended to be an all-inclusive list of deficiencies at your facility. As president of Medical Science Products, Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.
We acknowledge your letter dated June 20, 2005 responding to the FDA-483 Observations. Our review of the letter finds that it is inadequate in addressing all of the deficiencies listed on the FDA-483. With the exception of item number six, you have not provided enough detail in your response. Although it appears from your responses that you have promised to correct the deviations noted at your firm, you must adequately implement and maintain each corrective action to ensure its effectiveness.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the deviations listed above. In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Your written response to this Warning Letter should be sent to Mr. Stephen J. Rabe, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Mr. Rabe at (513) 679-2700, extension 163, or you may forward a facsimile to him at (513) 679-2773.
Carol A. Heppe