# FDA 483 - Bakelite Chemicals LLC - November 20, 2019

Source: https://www.globalkeysolutions.net/records/483/bakelite-chemicals-llc/9ed03716-d529-4486-b291-311f4588137d

> FDA 483 for Bakelite Chemicals LLC on November 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bakelite Chemicals LLC
- Inspection Date: 2019-11-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Georgia Pacific Chemical LLC in Albany, OR, was cited for significant deficiencies during an FDA inspection. Observations included a lack of appropriate controls over computerized laboratory systems, inadequate investigation of an out-of-specification result for formaldehyde, and incomplete batch production records lacking labeling copies. These issues indicate a moderate level of non-compliance with good manufacturing practices, particularly concerning data integrity and quality control.

## Related Officers

- [Compliance Officer - CDER/OC/OMQ](https://www.globalkeysolutions.net/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

Company: https://www.globalkeysolutions.net/companies/bakelite-chemicals-llc/77828887-3e5a-4cff-bcca-3423659055d3

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