# FDA 483 - PLZ Corp. - June 07, 2019

Source: https://www.globalkeysolutions.net/records/483/plz-corp/9f428547-3c07-4edb-a8e0-3967ebf42b29

> FDA 483 for PLZ Corp. on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PLZ Corp.
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: K-G Spray-Pak Inc. in Mississauga, an OTC drug manufacturer, was cited for significant deficiencies in its laboratory control and facilities and equipment systems. The inspection revealed issues with data integrity, including unreviewed audit trails and backups, inadequate computer system security procedures, and missing laboratory records. Additionally, the firm failed to properly qualify chromatographic software and perform routine calibration of mechanical equipment.

## Related Officers

- [Yumi Hiramine](https://www.globalkeysolutions.net/people/yumi-hiramine/26c5059f-8f61-42cf-ae79-65a7b942d2c7)

Company: https://www.globalkeysolutions.net/companies/plz-corp/885cbbe9-9517-4aca-8a72-f6e0b374439d

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1