# FDA 483 - Coupler LLC - August 12, 2021

Source: https://www.keypedia.com/records/483/coupler-llc/d85ef335-c090-477c-91ca-01a81a469667

> FDA 483 for Coupler LLC on August 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coupler LLC
- Inspection Date: 2021-08-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Coupler Enterprises, a contract packager in Warrington, PA, was inspected by the FDA from July 28 to August 12, 2021, revealing significant deficiencies in their manufacturing and quality control processes. The firm failed to adequately clean and maintain equipment, establish proper cleaning validation procedures, and ensure complete line clearance. Repeat observations highlight persistent issues with equipment design, quality control unit responsibilities, and labeling controls, indicating a high risk of product contamination and quality defects.

## Related Documents

- [483 - 2018-04-27](https://www.keypedia.com/records/483/coupler-llc/80e137b1-221a-47cb-b331-326591ce91c7)
- [483 - 2020-03-10](https://www.keypedia.com/records/483/coupler-llc/594e2801-eccf-40fe-8738-9421f4be351e)
- [483 - 2023-08-10](https://www.keypedia.com/records/483/coupler-llc/9fcb416e-67c9-4036-8992-b4dbe3bcce34)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ko-min/767a6604-9a34-49c7-8462-c763c2689f61)
- [Consumer Safety Officer](https://www.keypedia.com/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)
- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/coupler-llc/8427be09-3e40-4264-ab86-06be86855728

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248