# FDA 483 - Shertech Pharmacy - July 02, 2019

Source: https://www.keypedia.com/records/483/shertech-pharmacy/21e9ef74-75ad-4abf-a1cf-d33e7a5c3281

> FDA 483 for Shertech Pharmacy on July 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shertech Pharmacy
- Inspection Date: 2019-07-02
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Shertech Pharmacy in Easley, SC, a producer of sterile drug products, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in aseptic processing, environmental controls, product testing, and record-keeping, indicating a lack of adequate controls to ensure the sterility, quality, and purity of their drug products. These issues include using non-sterile gloves, inadequate cleanroom maintenance, poor facility design, lack of environmental monitoring, insufficient process validation, and failure to test finished sterile products for sterility and potency.

## Related Documents

- [483 - 2019-07-02](https://www.keypedia.com/records/483/shertech-pharmacy/f37624b0-9045-4fab-a2a9-f6e3a14ebb41)

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.keypedia.com/companies/shertech-pharmacy/0b691aa7-8df0-4573-8479-67b9dccaca5f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6