Company: Alpine Oral Care, LLC
Subject: CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issuer: Dallas District Office
Issued: Sept. 26, 2008 Closed:
Not applicable.
Source ucm1048116 Archive Code:

Alpine Oral Care, LLC 26-Sep-08

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

September 26, 2008

Ref: 2008-DAL-WL-24



Mr. Sean Moore, President
Alpine Oral Care, LLC
4003 Leeland Street
Houston, Texas 77023-3011

Dear Mr. Moore:

During an inspection of your firm located in Houston, Texas, on July 24, 28, and 30, 2008 , and August 4, 7, and 13, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm, a specification developer, manufactures and distributes mouth guards that are intended for protection against bruxism and nighttime teeth grinding, as stated in your firm's 510(k) K061122, and dental flossers. 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 are intended to affect the structure or any function of the body.

This. inspection revealed that these 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 (CFR), Part 820. The FDA investigator issued a list of inspectional observations, which are listed on the Form FDA 483, to the most responsible person at your firm at the time of the inspection (copy enclosed). Your manager verbally promised to correct the inspectional observations as annotated on the Form FDA 483. The violations include, but are not limited to,
the following:

Quality System Violations

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 C.F.R § 820.30(a). Specifically, your firm has not established written design control procedures that describe how it performs and documents each step of the design control process.

2. 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 § 820.300). Specifically, your firm has not maintained a design history file for the mouth guard devices to include documentation of design plans, design input requirements, design outputs, design reviews, design risk analysis, design changes, design verification or validation, and design transfer.

3. 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. Specifically, your firm has not (a) established specified requirements, including quality requirements, which must be met by your foreign contract manufacturer and domestic contract packager and any written agreements with them; and (b) documented any evaluation of their ability to meet these requirements.

4. 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 other requirements of 21 C.F.R § 820.198 are met. Specifically, your firm has not established complaint handling procedures for the receipt and evaluation of complaints.

5. Failure to establish and maintain procedures for the identification, documentation, evaluation, segregation, and disposition of products that do not fulfill specified requirements, as required by 21 C.F.R. § 820.96(a). Specifically, your firm has not established written procedures to control nonconforming product.

6. Failure to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of acceptance or rejection, as required by 21 C.F.R. § 820.80(b). Your manager stated that your firm received bulk and unlabeled mouth guards, pre-printed boxes, and product inserts (product labeling) from its foreign contract manufacturer, and then sent these products to your domestic packager for the final packaging. Your firm has not (a) established written procedures for the inspection, testing, or verification of these incoming products to ensure that they meet your firm's specified requirements; and (b) documented acceptance or rejection of the incoming products.

Our inspection also revealed that your firm's devices are 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 respecting the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 36t3i, and 21 C.F.R § 803 Medical Device Reporting (MDR) regulation. Your firm failed to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R § 803.17. Specifically, your firm did not have any written procedures for receiving, evaluating, and submitting MDR reports to the FDA.

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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 8 20) 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.



Reynaldo R. Rodriguez, Jr.
Dallas District Director

Ms. Cathy Teng, Manager
Alpine Oral Care, LLC
4003 Leeland Street
Houston, Texas 77023-3011