# FDA WARNING_LETTER - Alpine Oral Care, LLC - August 13, 2008

Source: https://www.keypedia.com/records/warning_letter/alpine-oral-care-llc/5a7e5e41-87ec-436d-b35a-41ac695527a1

> FDA WARNING_LETTER for Alpine Oral Care, LLC on August 13, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alpine Oral Care, LLC
- Inspection Date: 2008-08-13
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: On July 24, 28, 30, and August 4, 7, 13, 2008, the FDA inspected Alpine Oral Care, LLC in Houston, Texas, a specification developer manufacturing and distributing mouth guards and dental flossers. The inspection revealed the firm's devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include:
1.  Failure to establish and maintain design control procedures (21 CFR § 820.30(a)).
2.  Failure to maintain a device design history file for mouth guards (21 CFR § 820.30(j)).
3.  Failure to establish and maintain procedures for controlling purchased product and services, including requirements for and evaluation of foreign contract manufacturers and domestic packagers (21 CFR § 820.50).
4.  Failure to establish and maintain adequate complaint handling procedures (21 CFR § 820.198).
5.  Failure to establish and maintain procedures for nonconforming product control (21 CFR § 820.96(a)).
6.  Failure to establish and maintain procedures for acceptance or rejection

## Related Officers

- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)
- [Cathy Teng](https://www.keypedia.com/people/cathy-teng/6f05feee-b203-40e7-a6d1-df0cac9f3b80)

Company: https://www.keypedia.com/companies/alpine-oral-care-llc/58ad242b-1659-44df-b5d4-a0e8ba2c9fdc

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9