# FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - March 20, 2017

Source: https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/a15123c4-43cf-4ac7-b91b-ae2b1bc3e1de

> FDA 483 for Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany on March 20, 2017. 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: 2017-03-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Halo Pharmaceutical, Inc. in Whippany, NJ, a drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm lacked adequate written procedures for production controls, equipment cleaning, and reprocessing, and failed to thoroughly investigate out-of-specification results. Additionally, the facility's buildings were not maintained in a good state of repair, and raw materials were not stored to prevent contamination.

## Related Documents

- [EIR - 2017-03-20](https://www.globalkeysolutions.net/records/eir/halo-pharmaceutical-inc-dba-cambrex-whippany/bea5e98a-7d52-49f7-92d3-f6bee3c9ba28)
- [483 - 2019-12-20](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/9b43103a-df0c-4d52-949f-0dabcb89d760)
- [483 - 2023-02-17](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/85c16a13-185e-4160-8506-5e5d9a880e64)

## Related Officers

- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Director of Clinical Training](https://www.globalkeysolutions.net/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

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