- Panoramic Rental Corp.
- Issuing Office:
- Detroit District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
October 1, 2015
Young Innovations, Inc.
2260 Wendt Street
Algonquin, IL 60102
Dear Mr. Sproat:
During an inspection of your firm Panoramic Corporation located at 4321 Goshen Road, Fort Wayne, Indiana on April 15-24, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufacturers the Panoramic PC-1000 and PC-1000/Laser 1000 dental x-ray products. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. § 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 to affect the structure or any function of the body.
We received a response from Mr. Stephen T. Yaggy, Vice President, Panoramic Corporation, dated May 5, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to the noted violations.
Our inspection revealed that the PC-1000 Model Panoramic Dental X-Ray is misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
1. Failure to develop, maintain, and implement written MDR procedures for the following, as required by 21 CFR 803.17.
For example, after reviewing your firm’s MDR procedure titled: Procedure No. 7230 “Customer Communication”, Rev. E, Effective 2/19/13, the following issues were noted:
(1) Procedure No. 7230 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a)
(2) Procedure No. 7230 does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
(3) Procedure No. 7230 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The circumstances under which your firm must submit supplemental report and the requirements for such reports.
b. How your firm will submit all information reasonably known to it for each event.
We reviewed your firm’s response to this observation and concluded that it is not adequate. The revision to your SOP 9700 was not included in your response and therefore we were unable to evaluate the corrective action. Your response states you will be submitting the MDR reports in (b)(4). There was no evidence provided in the response that the initial (b)(4) reports had been filed. Also a review of (b)(4) years of service reports will be completed by the (b)(4). This is an ongoing correction and we are not able to evaluate at this time.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule have taken effect on August 14, 2015. If your firm is not currently submitting reports electronically we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReporabilityReviewTeam@fda.hhs.gov
Our Inspection also revealed that your firm’s PC-1000 and PC-1000/Laser-1000 devices are misbranded under section 501(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 806-Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Failure to report a correction or removal, conducted to reduce a risk to health posed by a device, or remedy a violation caused by a device which may present a risk to health, in writing to the FDA as required by 21 CFR 806.10.
For example, your firm initially alerted customers in a letter dated February 7, 2003, to a known issue which may cause the PC-1000 rotating arm/chassis to collapse to the base of the machine. A design change was made to the PC-1000 to correct the problem. After receiving additional complaints from the field on the PC-1000 rotating arm/chassis collapsing, your firm issued a second letter dated February 19, 2009. This field correction alerted customers to the issue with the PC-1000 machine and provided a warning label that was to be applied to the machine. The label stated: “Warning: If the column hesitates or sticks or you hear grinding noise during routine operation, immediately cease use of your PC-1000 unit and call the Panoramic corporation Service Department @ 1-800-654-2027. Failure to do so may result in patient /operator injury”.
Your firm has continued to receive complaints from customers of the rotating arm/chassis slipping. There have been (b)(4) complaints since 2009. This includes the most recent report, dated (b)(4), where a patient lost consciousness and had minor bruises after the x-ray machine slipped and struck the patient.
We reviewed your firm’s response to this observation and concluded that it is not adequate. Your corrective actions include a revision to the Recall SOP 8513. This SOP was not included with the response and therefore corrective actions cannot be verified.
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Catherine V. Quinlan, Compliance Officer, Food and Drug Administration at 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the contents of this letter, please contact Ms. Quinlan at (313)393-8153.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Art O. Czabaniuk
Detroit District Office
Copy to: Stephen T. Yaggy
4321 Goshen Road
Fort Wayne, IN 46818