# FDA 483 - PURETEK CORPORATION - October 24, 2024

Source: https://www.globalkeysolutions.net/records/483/puretek-corporation/35ddc87f-9bf7-4af6-86ca-32a5d95a7158

> FDA 483 for PURETEK CORPORATION on October 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PURETEK CORPORATION
- Inspection Date: 2024-10-24
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: PURETEK CORPORATION in Panorama City, CA, was issued a Form FDA 483 with two observations following an inspection from October 21-24, 2024. The firm failed to ensure equipment and utensils were cleaned at appropriate intervals, specifically by not validating cleaning for non-dedicated fillers and lacking data for clean/dirty hold times. Additionally, the company did not follow its own written cleaning procedures for filling equipment, leading to delayed cleaning of machinery used for both drug and dietary supplement products.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.globalkeysolutions.net/companies/puretek-corporation/3d5a41d5-bb8f-4397-8f08-ff159764af3d

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