# FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/85c16a13-185e-4160-8506-5e5d9a880e64

> FDA 483 for Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Halo Pharmaceutical, Inc. d/b/a Cambrex in Whippany, NJ, from February 7-17, 2023, identified a significant issue with equipment qualification. The firm was cited for using production equipment in commercial manufacturing that was not appropriately qualified for its intended use. This indicates a critical lapse in ensuring manufacturing equipment meets regulatory standards.

## Related Documents

- [EIR - 2017-03-20](https://www.globalkeysolutions.net/records/eir/halo-pharmaceutical-inc-dba-cambrex-whippany/bea5e98a-7d52-49f7-92d3-f6bee3c9ba28)
- [483 - 2017-03-20](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/a15123c4-43cf-4ac7-b91b-ae2b1bc3e1de)
- [483 - 2019-12-20](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/9b43103a-df0c-4d52-949f-0dabcb89d760)

## Related Officers

- [Maotang Zhou](https://www.globalkeysolutions.net/people/maotang-zhou/72134574-d2ac-4401-9058-d99c3885cc47)
- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)

Company: https://www.globalkeysolutions.net/companies/halo-pharmaceutical-inc-dba-cambrex-whippany/1464443d-ae5a-4d06-959c-d1ccb1b213a2

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248