# FDA 483 - OFD Foods LLC - Plant 2 - July 01, 2022

Source: https://www.globalkeysolutions.net/records/483/ofd-foods-llc-plant-2/72ba575e-9739-4751-9e30-24c6f24e505f

> FDA 483 for OFD Foods LLC - Plant 2 on July 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OFD Foods LLC - Plant 2
- Inspection Date: 2022-07-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: OFD Foods LLC in Albany, OR, a drug manufacturer, was cited for significant deficiencies in laboratory controls, including inadequate microbiological testing and environmental monitoring methods. The inspection also revealed failures in conducting thorough investigations into unexplained discrepancies and product rejections. Furthermore, the firm lacked proper change control for Master Batch Records, leading to inconsistent and unauthorized amendments.

## Related Officers

- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Sara H. Gabel](https://www.globalkeysolutions.net/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/ofd-foods-llc-plant-2/559d0cb6-67a2-4469-aafc-affe52c60b5c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822