# FDA 483 - James Alexander Corp. - February 27, 2019

Source: https://www.globalkeysolutions.net/records/483/james-alexander-corp/474497fc-da49-4b7c-ad2e-afce6dc5de89

> FDA 483 for James Alexander Corp. on February 27, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: James Alexander Corp.
- Inspection Date: 2019-02-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of James Alexander Corp in Blairstown, NJ, a drug contact manufacturer, revealed significant deficiencies in their quality control unit's written procedures. Specifically, the firm lacked approved procedures for handling deviations and change controls, with existing procedures remaining in draft status for approximately one year. This indicates a critical lapse in maintaining a robust quality system.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/james-alexander-corp/8dfac7e5-c873-4a95-b62d-f91607757994

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