# FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - May 04, 2021

Source: https://www.globalkeysolutions.net/records/483/dercher-enterprises-inc-dba-gordon-laboratories/b82415b2-6a92-4bca-9c97-d1f314e550df

> FDA 483 for Dercher Enterprises, Inc., DBA Gordon Laboratories on May 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dercher Enterprises, Inc., DBA Gordon Laboratories
- Inspection Date: 2021-05-04
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Dercher Enterprises, Inc., DBA Gordon Laboratories, an Upper Darby, PA drug manufacturer and repacker, was cited for significant deficiencies in its quality system. The inspection revealed failures in thoroughly investigating out-of-specification results and microbiological contamination, inadequate process and cleaning validations, and a lack of robust stability and raw material testing programs. These issues indicate a systemic failure to ensure drug product quality, purity, and identity.

## Related Documents

- [WARNING_LETTER - 2019-03-29](https://www.globalkeysolutions.net/records/warning_letter/dercher-enterprises-inc-dba-gordon-laboratories/9710fe6a-0c06-4a42-8a6f-1cb30e824780)
- [483 - 2022-06-13](https://www.globalkeysolutions.net/records/483/dercher-enterprises-inc-dba-gordon-laboratories/edb59598-e733-49b6-8c90-a98d31d0260c)
- [483 - 2023-09-20](https://www.globalkeysolutions.net/records/483/dercher-enterprises-inc-dba-gordon-laboratories/b9e690d3-f117-4aef-b93b-c8494df76da7)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/dercher-enterprises-inc-dba-gordon-laboratories/58d161b7-b2d3-477b-8837-e43087a3072b

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