# FDA EIR - Encompass Pharmaceutical Services Inc. - June 03, 2022

Source: https://www.keypedia.com/records/eir/encompass-pharmaceutical-services-inc/6a9d512e-0f1c-4b24-ae85-7b9e50cc9c74

> FDA EIR for Encompass Pharmaceutical Services Inc. on June 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Encompass Pharmaceutical Services Inc.
- Inspection Date: 2022-06-03
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The FDA conducted a comprehensive inspection of Encompass Pharmaceutical Services Inc. in Peachtree Corners, GA, from May 23 to June 3, 2022. Operating as a chemical/physical contract testing laboratory, the firm is subject to drug manufacturing regulations under the Food Drug and Cosmetic Act.The inspection revealed several significant issues, detailed in a Form FDA 483 issued to the owner, Thomas Rowe. Key violations included a systemic failure to initiate deviation and Out-of-Specification (OOS) investigations, particularly regarding stability chamber monitoring deficiencies such as missing temperature/humidity records and prolonged OOS conditions. The firm also lacked adequate stability data to support drug product expiration dates, largely due to non-functional continuous monitoring systems, insufficient raw chart recorder data, and conflicts between documented logbook entries and raw data. Furthermore, controls over computer systems were inadequate, with data integrity Standard Operating Procedures (SOPs) failing to properly address audit trail reviews, a recurring issue from a 2019 Health Canada audit. Lastly, routine equipment calibration was found deficient, with missing or inadequate SOPs for stability chamber operation and sensor calibration.Management, through Mr. Rowe, acknowledged the observations and committed to submitting a written response to the FDA 483 within 15 business days, including efforts to retrieve missing data. The firm was reminded of its ongoing responsibility to comply with regulatory requirements, with potential consequences ranging from warning letters to legal penalties for non-compliance.

## Related Documents

- [483 - 2022-06-03](https://www.keypedia.com/records/483/encompass-pharmaceutical-services-inc/3c0c9070-cb3e-40ae-ba32-fb8f1d5027c2)

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/encompass-pharmaceutical-services-inc/42c093ab-f3bc-421b-8622-2450df89f843

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7