# FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - June 13, 2022

Source: https://www.keypedia.com/records/483/dercher-enterprises-inc-dba-gordon-laboratories/edb59598-e733-49b6-8c90-a98d31d0260c

> FDA 483 for Dercher Enterprises, Inc., DBA Gordon Laboratories on June 13, 2022. 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: 2022-06-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Dercher Enterprises, Inc., DBA Gordon Laboratories in Upper Darby, PA, was cited for four observations during an FDA inspection. The firm lacks a comprehensive stability testing program, leading to unsupported product expiration dates and inadequate sample storage. Additionally, the quality control unit's responsibilities and procedures are not fully documented or followed, particularly concerning vendor assessment and change control for product formulations and processes.

## Related Documents

- [WARNING_LETTER - 2019-03-29](https://www.keypedia.com/records/warning_letter/dercher-enterprises-inc-dba-gordon-laboratories/9710fe6a-0c06-4a42-8a6f-1cb30e824780)
- [483 - 2021-05-04](https://www.keypedia.com/records/483/dercher-enterprises-inc-dba-gordon-laboratories/b82415b2-6a92-4bca-9c97-d1f314e550df)
- [483 - 2023-09-20](https://www.keypedia.com/records/483/dercher-enterprises-inc-dba-gordon-laboratories/b9e690d3-f117-4aef-b93b-c8494df76da7)

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)
- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

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

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