# FDA 483 - NeoBiotech Global Corporation - May 13, 2019

Source: https://www.keypedia.com/records/483/neobiotech-global-corporation/29d9b353-4bfe-4546-852d-4233471d80b5

> FDA 483 for NeoBiotech Global Corporation on May 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeoBiotech Global Corporation
- Inspection Date: 2019-05-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: NeoBiotech Global Corporation, an OTC drug manufacturer in Auburn, WA, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked a functional quality control unit, written procedures for critical operations like complaint handling, raw material control, batch production, and process validation. Additionally, the inspection revealed inadequate control over equipment, labeling, and a complete absence of analytical testing for drug product release, indicating a severe lack of fundamental GMP compliance.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)
- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/neobiotech-global-corporation/30365711-56f1-4ed4-80ca-ae4b6926b119

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