# FDA 483 - Coupler LLC - April 27, 2018

Source: https://www.globalkeysolutions.net/records/483/coupler-llc/80e137b1-221a-47cb-b331-326591ce91c7

> FDA 483 for Coupler LLC on April 27, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Coupler LLC
- Inspection Date: 2018-04-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Coupler Enterprises, a contract drug repackager in Warrington, PA, was cited for significant deficiencies during an FDA inspection. The observations highlight a lack of fundamental quality control systems, including no designated quality unit, inadequate equipment cleaning and maintenance procedures, and an absence of a stability testing program for repackaged drugs. These issues indicate a severe lack of control over critical manufacturing and packaging processes.

## Related Documents

- [483 - 2020-03-10](https://www.globalkeysolutions.net/records/483/coupler-llc/594e2801-eccf-40fe-8738-9421f4be351e)
- [483 - 2023-08-10](https://www.globalkeysolutions.net/records/483/coupler-llc/9fcb416e-67c9-4036-8992-b4dbe3bcce34)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

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

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