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

Source: https://www.keypedia.com/records/483/tenco-assemblies-inc/d88211ad-8d5b-44c8-8f21-fccb1fc77008

> 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: Philadelphia District Office
- Summary: Tenco Assemblies, Inc. in Morrisville, PA, a repackager and relabeler, was inspected by the FDA from August 5-7, 2024. The inspection revealed two significant observations related to inadequate record-keeping for equipment maintenance and improper storage conditions for reserve drug product samples. These issues indicate potential non-compliance with good manufacturing practices for drug products.

## Related Documents

- [483 - 2025-11-14](https://www.keypedia.com/records/483/tenco-assemblies-inc/77ae35ad-1fc2-4d19-886a-fd2349c40cf7)

## Related Officers

- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

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

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8