# FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - September 20, 2023

Source: https://www.globalkeysolutions.net/records/483/dercher-enterprises-inc-dba-gordon-laboratories/b9e690d3-f117-4aef-b93b-c8494df76da7

> FDA 483 for Dercher Enterprises, Inc., DBA Gordon Laboratories on September 20, 2023. 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: 2023-09-20
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Dercher Enterprises, Inc., DBA Gordon Laboratories, an OTC drug manufacturer in Upper Darby, PA, received a Form 483 with nine observations during an inspection from September 11-20, 2023. The inspection revealed significant deficiencies in process validation, stability testing, component testing, quality control unit responsibilities, and record-keeping, with several issues being repeat observations from previous inspections. The firm also failed to maintain adequate cleaning procedures, proper storage conditions, and sanitary facility conditions.

## 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)
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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)
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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
