# FDA 483 - Tenco Assemblies, Inc. - August 07, 2024

Source: https://www.keypedia.com/records/483/tenco-assemblies-inc/20a09361-6e28-4640-be74-7fddcf2a389f

> FDA 483 for Tenco Assemblies, Inc. on August 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tenco Assemblies, Inc.
- Inspection Date: 2024-08-07
- Product Type: drugs
- Office Name: Dallas District, Fort Worth Resident Post
- Summary: Tenco Assemblies, Inc., a repackager and relabeler based in Morrisville, PA, was subject to an FDA inspection from August 5-7, 2024. The inspection resulted in two key observations indicating non-compliance with regulatory standards.

The first observation concerned inadequate record-keeping for equipment maintenance. Specifically, the firm did not record the use of certified weights for the recalibration of scales employed as in-process product weight checkers during repackaging. This oversight impacts the assurance of measurement accuracy for critical equipment.

The second observation revealed deficiencies in the storage and retention of reserve drug product samples. Tenco Assemblies, Inc. failed to monitor or maintain temperature records for its retain sample room, where distributed Over-the-Counter (OTC) drug products are stored. This practice is essential for ensuring that samples are kept under conditions consistent with product labeling and for maintaining product integrity.

These observations, issued under the Federal Food, Drug, and Cosmetic Act, highlight practices requiring corrective action. While the FDA Form 483 is not a final determination of compliance, Tenco Assemblies, Inc. is expected to respond by outlining corrective measures to address the identified issues and prevent their recurrence, ensuring adherence to regulatory requirements.

## Related Documents

- [483 - 2024-08-07](https://www.keypedia.com/records/483/tenco-assemblies-inc/d88211ad-8d5b-44c8-8f21-fccb1fc77008)
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## Related Officers

- [Phillip C. Trefsgar](https://www.keypedia.com/people/phillip-c-trefsgar/8034282c-6b16-46e7-9a56-dbe32e0b99dd)

Company: https://www.keypedia.com/companies/tenco-assemblies-inc/35752eee-7db3-4e91-9902-ca494be7ac3e

Office: https://www.keypedia.com/offices/dallas-district-fort-worth-resident-post/4c0a9dac-ff7f-49c2-9f90-aa7537236b2a