Inspections, Compliance, Enforcement, and Criminal Investigations
Tingle X-Ray Products, Inc. 12-Jun-07
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
June 12, 2007
WARNING LETTER NO. 2007-NOL-12
Jerry M. Tingle, President
Tingle X-Ray Products, Inc.
5481 Skyland Boulevard East
Cottondale, Alabama 35453-1789
Dear Mr. Tingle:
During an inspection of your firm, located at 5481 Skyland Boulevard East, Cottondale, Alabama, on February 21 - 23 and March 2, 2007, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures x-ray controls and is an initial importer of x-ray tables. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 321(h)), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (21 CFR), Part 820. At the close of the inspection, a Form FDA 483 was issued to you listing violations of the Act. These violations include, but are not limited to, the following:
1. You failed to conduct all finished device acceptance activities. A review of the TXR 325D x-ray control device master record file, conducted after the inspection, noted it contained a reproducibility test to be conducted at the following machine settings: [redacted] However, TXR 325D control, serial number 30678, was not tested according to the previously stated specifications [21 CFR 820.80(d)].
2. You failed to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, you failed to establish procedures for the following:
a. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems [21 CFR 820.100(a)(1)];
b. Investigating the cause of nonconformitics relating to product, processes, and the quality system [21 CFR 820.100(a)(2)];
c. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems [21 CFR 820.100(a)(3)];
d. Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device [21 CFR 820.100(a)(4)];
e. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems [21 CFR 820.100(a)(5)];
f. Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems [21 CFR 820.100(a)(6)]; and,
g. Submitting relevant information on identified quality problems, as well as CAPA, for management review [21 CFR 820.100(a)(7)].
3. You failed to review and evaluate all complaints to determine whether an investigation is necessary [21 CFR 820.198(b)]. Specifically, a review of approximately 350 service reports revealed at least 50 percent should have been handled in accordance with the quality system complaint handling requirements. For example, the following service reports were not dated, documented as a complaint, or investigated:
a. Service report number [redacted], regarding x-ray controller, serial number 27161, which states, "Won't expose after few exposures...when unit was off for sonic time, turning unit on will make exposure.";
b. Service report number [redacted], regarding overlay, serial number 28930, which states, "The overlay failed in operation.";
c. Service report number [redacted], regarding selector switch, serial number 27896, which states, "mA selector short circuited internally and seems to be welded within contacts.";
d. Service report number [redacted], which states, "KVP light going out and partial exposures."; and,
e. Service report number [redacted], regarding rotor board, no serial number indicated, which states, "Intermittent No Exposure."
4. You failed to track changes to documents to ensure only the most current version is being used in your operations. For example, the master device record, device history records, service records, standard operating procedures, and quality assurance procedure manual for the TXR 325D x-ray control did not contain change controls. The master device record file for the TXR 325D x-ray control contained an additional reproducibility test which was not used during testing of that product with serial number 30678 [21 CFR 820.40(b)].
5. You failed to include all specifications within your device master records. Specifically, the device master record of the TXR high voltage 325D x-ray control does not include the software number of the timer or the release criteria used for the 325-1 high voltage transformer [21 CFR 820.181(a)].
6. You failed to document the training of employees. Specifically, your firm has not documented the training of the Quality Clerk, who is responsible for reviewing the quality assurance final testing documentation. Your firm has no documentation demonstrating the Quality Clerk has the necessary education, background, training, and experience to assure the final testing was correctly performed [21 CFR 820.25].
7. You failed to appoint a management representative to oversee your quality system and to report to management on the system's performance [21 CFR 820.20(b)(3)].
Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information required by or Under Section 519 of the Act, [21 USC 360i], and 21 CFR 803 - Medical Device Reporting (MDR) regulation. Specifically, you failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
We have received your response letter dated April 2, 2007, concerning our investigator's observations on the Form FDA 483. We have reviewed the letter and concluded your response is inadequate for the following reasons:
1. You have not provided a procedure addressing all aspects of "Corrective and Preventive Action" as stated above.
2. You provided a procedure for addressing MDR reportable events. The procedure is not adequate because it refers to FDA's MDR procedures, rather than clearly spelling out the steps which must be taken.
a. You must address your own time frames, procedures, and the name of MDR contacts employees should notify as soon as they become aware of an event is subject to MDR reporting.
b. Your MDR procedures call for reporting only "death and serious injuries to which a device has or may have caused or contributed to their injury." Your procedures do not address a device malfunction which would be likely to cause or contribute to a death or serious injury if the malfunction were to recur [21 CFR 803.40(b)].
c. Your complaint handling procedure SOP Number 3 addresses complaints involving products received from foreign manufacturers. You state the complaints "shall be treated as if it were our own equipment and will be handled the same as any other complaint." However, it does not address the persons responsible for reporting the complaint to the foreign manufacturer. As stated above, your procedure does not address an imported device malfunction which would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
You should take prompt action to correct the violations addressed in this letter. 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, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters concerning devices so they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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 violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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 U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer at the above address. If you have any questions about the content of this letter, please contact Mr. Rivero at (504) 219-8818 x 103.
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483