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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Frantz Design, Inc

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 5,2009


Ref: 2009·DAL-WL·12


WARNING LETTER


CERTIFIED MAIL
RETURNED RECEIPT REQUESTED


Mr. Joe Lee Frantz
Vice President and Co-Owner
Frantz Design, Inc.
3202 Oakmont Blvd.
Austin, Texas 78703-1346


Dear Mr. Frantz:


During an inspection of your firm located at the above-referenced address on February 19 through March 5, 2009, an investigator from the United States Food and Drug Administration (FDA or Agency) determined that your firm, a specification developer, manufactures the Elastic Mandibular Advancement (EMA) Appliance Kit which is an oral dental device indicated for the treatment of obstructive sleep apnea and snoring as stated in 510(k) K971794. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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 any function of the body.


This inspection revealed that your devices are adulterated within the meaning of 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R), Part 820.


The FDA investigator issued the observations, which are listed on the Form FDA 483 (List of Inspectional Observations), to you at the end of the inspection. You verbally promised to correct the inspectional observations as annotated on the Form FDA 483. The Agency requires you take timely, effective corrective actions to correct your firm's lack of quality system procedures and records, and expects your firm to work closely with the contract manufacturer and dental laboratories to correct quality issues of your devices and prevent them from recurring in the future.


The inspection revealed that between March 31 and April 10, 2008, your firm retrieved from commerce defective blue elastic straps of the EMA devices from (b)(4) dental laboratories and replaced them with the new ones in response to several complaints of the blue elastic straps breaking during patient's use. To determine whether or not future product corrections or removals must be reported to the Agency as a reportable product recall under 21 C.F.R. §§ 806.10 and 806.20, we encourage your firm to contact our Recall Coordinator at 214-253-5222.


FDA follow-up inspections will be necessary to assure that your firm's corrections are adequate. The violations include, but are not limited to, the following:


Quality System Violations


1. Failure of the management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 C.F.R. § 820.20. See FDA 483 Items 1 through 15.


Specifically, your firm has not conducted quality audits of your firm and your contract manufacturer and established adequate procedures and records for complaint handling, MDR reporting, purchasing controls, design change controls, implementation of corrective and preventive actions, acceptance activities, and packaging and labeling activities. In March 2008, after receiving several complaints of the blue elastic straps breaking during patient's use, your firm removed all blue straps from  (b)(4)  dental laboratories and replaced the defective straps with the new straps in April 2008. The elastic straps are used to pull the mandible forward in order to increase the patient's airspace, thereby decreasing upper airway obstruction.


2. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 C.F.R. § 820.30(i). FDA 483 Item 2.


Specifically, your firm has not established written procedures describing how it evaluates, verifies or validates, documents, and approves design changes. Your firm has not maintained records of approved design changes and verification or validation results of the design changes. For instance, your firm explained to the investigator that in 2007 it changed the (b)(4) of the (b)(4) to address verbal "feedback" of cheek irritation from some patients, and the device assembly instructions to be used by your dental laboratories. Another instance, in March 2008 after receiving several complaints of the blue elastic straps breaking during patient's use, your firm instructed the contract manufacturer not to use the (b)(4) that weakened the strength of the elastic straps during the injection molding process and subsequently made a change to the (b)(4) in order to increase the strength of the elastic straps.


3. Failure to establish and maintain a device design history file for each type of device to include or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 C.F.R. § 820. as required by 21 C.F.R. § 820.30U). See FDA 483 Item 3.


Specifically, other than some product brochures that list the length and firmness specifications of the elastic straps, your firm has not maintained a design history file to document the design changes made to the EMA devices and their injection molding process as described above.


4. Failure to validate with a high degree of assurance a manufacturing process whose results cannot be fully verified by subsequent inspection or test, approve the validation according to established procedures, and document validation results and activities, as required by 21 C.F.R. § 820,75(a); and failure to revalidate a manufacturing process when changes or process deviations occur, as required by 21 C.F.R. § 820.75(c). See FDA 483 Items 4 and 14.


Specifically, neither your firm nor your contract manufacturer has validated the injection molding process used to manufacture the devices' elastic straps in order to detect problems and ensure that this product consistently meets its quality specifications. For instance, the use of the (b)(4) material during the injection molding process caused the blue elastic straps to break during patient's use in March 2008. Further, your firm has not revalidated the injection molding process when your firm changed the (b)(4) to increase the strength of the elastic straps in response to complaints of broken elastic straps.


5. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. § 820.50. See FDA 483 Item 13.


Specifically, your firm has not established written procedures or a signed contract agreement that delineate the specific responsibilities and manufacturing operations to be performed by your firm and your contract manufacturers, and the quality requirements to be met by your contract manufacturers.


6. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 C.F.R. § 820.198 are met. See FDA 483 Item 6.


Specifically, your firm has not established complaint handling procedures to ensure that all verbal and written complaints are documented and evaluated. For instance, your firm received verbal "feedback" of cheek irritation from some patients, but did not document these complaints.


7. Failure to establish and maintain procedures to control labeling activities, including labeling inspection, labeling storage, and labeling operations, in order to ensure that printed labels remain legible, as required by 21 C.F.R. § 820.120. See FDA 483 Item 15.


Specifically, your firm has not established labeling procedures for how to label your packaged EMA devices and inspect the product label. There was no printed label on the device packaging. Your firm hand wrote the product description, quantity, and manufacturing dates on the (b)(4) bags.


8. Failure to establish and maintain procedures to ensure that the device history records (DHR) for each batch, lot, or units are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 C.F.R. § 820.184. FDA 483 Item 11.


Specifically, your firm has not established DHR procedures to define what quality attributes or device specifications are to be inspected, tested, or verified as conforming to specified requirements and where acceptance/rejection results are to be reviewed and documented. The DHR shall include the dates of manufacture, the quantity manufactured, and the quantity released for distribution.


Reports of Corrections and Removals and Medical Device Reporting


Our inspection revealed that your above-referenced devices are also misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to furnish material or information respecting the devices that is required by or under (a) Section 519(f)(1) of the Act, 21 U.S.C. § 360i(f)(1), and 21 C.F.R. § 806 - Reports of Corrections and Removals; and (b) Section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. § 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to the following:

1. Failure to maintain a record of such correction or removal action that is not required to be reported to the FDA under 21 C.F.R. § 806.10, and failure to ensure that all the requirements of 21 C.F.R. § 806.20 are met. See FDA 483 Item 10.


Specifically between March 31 and April 10, 2008 your firm removed all blue elastic straps from (b)(4) dental laboratories in response to several complaints of the straps breaking during patient's use. Your firm has not maintained a record to document your justification for not reporting this removal action to the Agency. the quantity of the devices removed, the dates of the removal, and the status of the removal.


2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. § 803.17. See FDA 483 Item 9.


Specifically, your firm did not have written MDR procedures for receiving and evaluating medical adverse events and submitting reportable medical adverse events as MDR reports to the FDA. For example, in March 2008 your firm received several complaints of the blue elastic straps breaking during patient's use. Your firm did not document whether any medical adverse events had occurred to the patients, and your evaluation to determine whether or not these complaints are reportable to the FDA. In 2007, your firm received verbal "feedback" of cheek irritation from some patients. Your firm was unable to provide specific information of how many patients had cheek irritation and whether any medical treatment was performed because your firm did not document these complaints.


Responding to This Warning Letter


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 about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation (21 C.F.R. Part 820) deviations are reasonably related will not be approved until the violations have been corrected. 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 violations, 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 Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.


Finally, you should know that 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 FDA 483 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.


Sincerely,

/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director


RRR:txt


cc: Dr. Donald Frantz, D.D.S.
President and Co-owner

(b)(7)(c)