# FDA 483 - Lifetech Resources, LLC - April 05, 2019

Source: https://www.globalkeysolutions.net/records/483/lifetech-resources-llc/79d0219f-a680-4f52-820b-497501e581b0

> FDA 483 for Lifetech Resources, LLC on April 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lifetech Resources, LLC
- Inspection Date: 2019-04-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Lifetech Resources, LLC in Moorpark, CA, an OTC drug and cosmetic manufacturer, identified two significant observations. The firm failed to establish and follow written procedures for equipment cleaning and maintenance, specifically lacking cleaning validation for non-dedicated equipment used in OTC drug manufacturing. Additionally, the firm did not complete required annual product reviews for its OTC drug products for 2017 and 2018, indicating deficiencies in its quality system.

## Related Documents

- [483 - 2025-03-03](https://www.globalkeysolutions.net/records/483/lifetech-resources-llc/e7b3b255-dcf4-4093-a30f-60605d651677)

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

Company: https://www.globalkeysolutions.net/companies/lifetech-resources-llc/9eddae9c-bced-43d5-adb8-b305b687829d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6