# FDA 483 - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - December 20, 2019

Source: https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/9b43103a-df0c-4d52-949f-0dabcb89d760

> FDA 483 for Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany on December 20, 2019. 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: 2019-12-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Halo Pharmaceuticals (DBA Cambrex Whippany) in Whippany, NJ, a drug manufacturer, was inspected by the FDA. The inspection revealed significant issues with the firm's warehousing procedures for drug products, including a lack of established procedures and failure to properly track materials in their ERP system. Additionally, the quality control unit was found to be non-compliant with its own procedures for handling and closing investigations, leading to numerous overdue investigations.

## 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 - 2023-02-17](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-inc-dba-cambrex-whippany/85c16a13-185e-4160-8506-5e5d9a880e64)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/zhijin-chen/83b97abc-e295-4085-ac58-a4e7349620be)
- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)
- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/emmanuel-j-ramos/ba0666bd-2752-453e-9fd3-5e43b1cff3ad)

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