Inspections, Compliance, Enforcement, and Criminal Investigations
Tek Marketing, Inc 22-May-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
Mr. John Hope, President/Owner
Tek Marketing, Inc., d.b.a. Hope X-Ray
98 Railroad Drive,
Warminster, PA 18974-1454
Dear Mr. Hope:
During an inspection of your establishment located in Warminster, Pennsylvania, ending on March 16, 2006, our investigator determined that your firm is a manufacturer of automatic radiographic film processors, such as the Micro Max, Podo Max, Dental Max and Hi Cap II. Radiographic film processors are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)].
The above-stated inspection revealed that your devices are adulterated under section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Your devices may also be misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)], because your firm failed to establish and maintain written medical device reporting (MDR) procedures, as required by section 519 of the Act [21 U.S.C. § 36.011 and the MDR regulation, 21 CFR, Part 803. Significant deviations include, but are not limited to, the following:
1. Failure to establish a quality policy that assures that the Quality System Regulation requirements are effectively recognized and upheld. [21 CFR 820.20]
Management with executive responsibility has not ensured that an effective quality system is established, implemented and maintained. You have not established written procedures for management controls, design controls, and corrective/preventative action. You have not established or conducted a quality policy, quality plan, quality audits, or management reviews.
2. Failure to establish and maintain procedures for handling complaints. [21 CFR 820.198 and 21 CFR, Part 803]
You have not developed and maintained procedures for handling complaints. This is a basic QSR requirement. During the current inspection, the investigator was told that you have not received any complaints; however when he examined your binder that contains hand-written service calls, he found that some of the service calls were complaints, and were not treated as such. Additionally, you have no provisions for handling complaints which may fall under the MDR regulation.
3. Failure to establish procedures to control the design process and design changes. [21 CFR 820.30(a) and 21 CFR 820.30(i)]
The design and development of the Podo Max and Dental Max processors were not developed in accordance with any established design controls. Design controls are necessary to ensure that specified design requirements are met. Additionally, procedures were not established for design changes prior to their implementation. For example, the following design changes to the Podo Max were made with no design change procedures in place: a redesigned printed circuit board, changing pot controls for replenishers and developer, and redesigning heat sinks.
4. Failure to establish procedures for acceptance of incoming components. [21 CFR 820.80(a)]
The inspection revealed that you have no procedures to determine the acceptance/rejection of components prior to use in a finished device .
5. Failure to document the calibration of test equipment. [21 CFR 820.72(b)(2)]
There is.no documentation indicating that finished product test equipment has been calibrated (for example, [redacted] and [redacted]
6. Failure to document finished device acceptance/rejection activities. [21 CFR 820.80(d)]
Production records for three of seventeen finished devices, reviewed by the investigator, were found to be released without conducting and/or documenting finished device inspection tests. Production records for the three devices had missing QAARs (quality assurance audit reports) which are used to document finished device testing.
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 Food and Drug Administration (FDA) regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
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. Additionally, no premarket submissions for Class III devices to which the Quality System Regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for the Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations . Failure to promptly correct these deviations may result in regulatory action being initiated without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this' office in writing within 15 working 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 prevent the recurrence of similar violations. 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 should be sent to Richard C. Cherry, Compliance Officer, at U.S. Customhouse, Room 900,200 Chestnut Street, Philadelphia, PA 19106.
Thomas D. Gardine
Philadelphia District Office