# FDA 483 - PureTek Corporation - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/puretek-corporation/9d4c89d7-2ea2-4e56-accd-6b608d97051a

> FDA 483 for PureTek Corporation on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PureTek Corporation
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: PureTek Corporation, a drug manufacturer in San Fernando, CA, received a Form 483 with two observations. The inspection revealed deficiencies in documenting on-the-job training for employees performing GMP operations and a failure to limit access to the storage area for labels and labeling materials to authorized personnel. These findings indicate issues with personnel qualification and material control.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Lena Nguyen](https://www.globalkeysolutions.net/people/lena-nguyen/99d85719-61c2-40bb-8358-0f3a98747e0d)

Company: https://www.globalkeysolutions.net/companies/puretek-corporation/428846ad-3d0d-4e9e-9b5e-41321940234c

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b