# FDA 483 - Span Packaging Services LLC - May 02, 2025

Source: https://www.globalkeysolutions.net/records/483/span-packaging-services-llc/6d533df6-2c7f-48e2-b055-0f0e4c8ee71d

> FDA 483 for Span Packaging Services LLC on May 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Span Packaging Services LLC
- Inspection Date: 2025-05-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Span Packaging Services LLC, a contract manufacturer in Greenville, SC, was inspected and cited for significant deficiencies in its manufacturing and laboratory controls. Observations included a lack of established procedures, environmental monitoring, and validations for sterile drug products, as well as inadequate laboratory testing for finished products and unverified bulk product testing methods. The firm also failed to thoroughly review unexplained discrepancies and out-of-specification stability failures, lacking proper root cause analysis.

## Related Documents

- [483 - 2023-06-15](https://www.globalkeysolutions.net/records/483/span-packaging-services-llc/e2784144-efed-4d30-bbfb-0106922140a7)

## Related Officers

- [Dorothy P. Kramer](https://www.globalkeysolutions.net/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)

Company: https://www.globalkeysolutions.net/companies/span-packaging-services-llc/21d0cf8e-26d5-421d-8460-5edd657878e9

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