# FDA 483 - Pt Dua Kelinci - August 23, 2023

Source: https://www.globalkeysolutions.net/records/483/pt-dua-kelinci/4a29c18a-dd74-4a05-b90c-f9f058145a80

> FDA 483 for Pt Dua Kelinci on August 23, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pt Dua Kelinci
- Inspection Date: 2023-08-23
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pt Dua Kelinci, a manufacturer in Pati, Indonesia, was cited with two observations during an FDA inspection regarding significant sanitation and cleaning deficiencies. The firm failed to adequately clean and sanitize utensils and equipment, leading to potential allergen cross-contact and contamination of food. Additionally, the plant was not maintained in a clean and sanitary condition or in adequate repair, with widespread observations of built-up food debris and inadequate cleaning processes.

## Related Documents

- [WARNING_LETTER - 2023-08-23](https://www.globalkeysolutions.net/records/warning_letter/pt-dua-kelinci/492fc9d3-7658-4ee8-a2c7-254ac164f9b5)

## Related Officers

- [Brandi Williams](https://www.globalkeysolutions.net/people/brandi-williams/f13d1828-b075-47a9-b979-7bbd393e0277)

Company: https://www.globalkeysolutions.net/companies/pt-dua-kelinci/78ee96b3-e31f-4cf9-95ec-aa6595928190

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