# FDA 483 - SGS Chemical Solutions Laboratories Inc. - August 22, 2018

Source: https://www.globalkeysolutions.net/records/483/sgs-chemical-solutions-laboratories-inc/7a74d8fc-c26d-421d-a102-0fbca92109c5

> FDA 483 for SGS Chemical Solutions Laboratories Inc. on August 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGS Chemical Solutions Laboratories Inc.
- Inspection Date: 2018-08-22
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Chemical Solutions Ltd. in Harrisburg, PA, a control testing lab, was cited for two significant observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems, allowing analysts to delete and alter electronic raw data without an audit trail, which was noted as a repeat observation. Additionally, laboratory records were found deficient, lacking proper documentation for sample receipt, quantity, and disposal for both non-controlled drug products and finished products.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sgs-chemical-solutions-laboratories-inc/972c1151-b936-417c-8168-828eae7cd65d

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