# FDA 483 - Universal Packaging Systems, Inc. - March 05, 2019

Source: https://www.globalkeysolutions.net/records/483/universal-packaging-systems-inc/efb2acf6-f467-467d-895b-cf1505cc80e9

> FDA 483 for Universal Packaging Systems, Inc. on March 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Universal Packaging Systems, Inc.
- Inspection Date: 2019-03-05
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: PakLab dba Universal Packaging Systems Inc, a device and drug repacker in Batavia, OH, was cited for significant deficiencies across its quality system during an FDA inspection. The report details widespread issues including inadequate corrective and preventive actions, unvalidated processes, poor control of non-conforming materials, and insufficient supplier and change management. These findings indicate a systemic lack of adherence to established procedures and regulatory requirements, posing a high risk to product quality and patient safety.

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)
- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.globalkeysolutions.net/companies/universal-packaging-systems-inc/05c582ba-6552-40e4-bc6f-b6a751e91689

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22