# FDA 483 - KarePak, LLC - October 09, 2019

Source: https://www.keypedia.com/records/483/karepak-llc/d5a1c286-ceb7-43be-ab85-6d5f8be7cd84

> FDA 483 for KarePak, LLC on October 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KarePak, LLC
- Inspection Date: 2019-10-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: KarePak, LLC, an OTC drug repacker and relabeler in Oakdale, CA, was cited for two observations during an FDA inspection. The firm failed to follow written procedures for equipment cleaning and maintenance, with equipment found unlabeled and not thoroughly cleaned. Additionally, the company's reserve drug product samples were insufficient, not meeting the required quantity for all necessary tests.

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/karepak-llc/281cccb6-1e00-4e1f-a237-bcb34ea25c09

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b