# FDA WARNING_LETTER - Tra & Accessories - September 27, 2010

Source: https://www.keypedia.com/records/warning_letter/tra-accessories/39eb002e-d39c-4548-93fd-9490d6759e61

> FDA WARNING_LETTER for Tra & Accessories on September 27, 2010. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Tra & Accessories
- Inspection Date: 2010-09-27
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On February 1, 2011, the FDA issued a Warning Letter to Tra & Accessories, a manufacturer (specification developer, repacker/relabeler) of Tono-Pen Tonometer Tip Covers. An inspection from September 8-27, 2010, revealed the devices are adulterated and misbranded.

Violations of the Quality System (QS) regulation (21 CFR Part 820) include:
1.  **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain adequate design control procedures, lacking documentation for design input, output, review, verification, validation, changes, and a design history file. Only a "blue print" drawing was maintained.
2.  **Purchasing Controls (21 CFR 820.50(a)):** Failure to establish requirements for suppliers (e.g., Profound Rubber Industries) and lacking quality documents or agreements for supplier qualification.
3.  **Environmental Control (21 CFR 820.70(c)):** Failure to control environmental conditions where products are exposed to an uncontrolled warehouse environment during receiving and repackaging.
4.  **Incoming Product Acceptance (21 CFR 820.80(b)):** Failure to establish procedures and criteria for incoming product acceptance, including a statistically valid sampling plan.
5.  **Equipment Maintenance (2

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/tra-accessories/cfec06e6-705a-4a9d-a39a-3b66e5f95b8f

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b