# FDA 483 - Sharp Packaging Services, LLC - September 21, 2022

Source: https://www.keypedia.com/records/483/sharp-packaging-services-llc/131ffb10-4021-427f-b3d6-d567ff906c4c

> FDA 483 for Sharp Packaging Services, LLC on September 21, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharp Packaging Services, LLC
- Inspection Date: 2022-09-21
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sharp Packaging Services, LLC in Allentown, PA, received a Form 483 following an inspection from September 19-21, 2022. The inspection revealed significant deficiencies related to the manufacturing of sterile products, including inadequate procedures for preventing microbiological contamination, insufficient sterilization process validation, and a lack of controls for electronic data acquisition systems. Additionally, the firm failed to establish adequate cleaning and decontamination procedures for product-contact equipment.

## Related Documents

- [483 - 2019-04-24](https://www.keypedia.com/records/483/sharp-packaging-services-llc/2cc93f19-912d-4f39-b542-23c75ca281be)
- [483 - 2022-01-28](https://www.keypedia.com/records/483/sharp-packaging-services-llc/6146240c-7eb8-4086-9741-44f456638f4a)

## Related Officers

- [Zhong Li, PhD, Sr.](https://www.keypedia.com/people/zhong-li-phd-sr/52d25f38-4b32-4911-afbc-a49e9baba7d0)
- [Esther C. Broner](https://www.keypedia.com/people/esther-c-broner/5df7ca72-a21f-4586-a5e0-8a782045281c)

Company: https://www.keypedia.com/companies/sharp-packaging-services-llc/94d213d1-e9ba-4a96-afc2-9e8f37b6c9d8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd