# FDA 483 - J. B. Chemicals and Pharmaceuticals Limited - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/j-b-chemicals-and-pharmaceuticals-limited/0c743771-fa73-4295-a046-de7c1507c61f

> FDA 483 for J. B. Chemicals and Pharmaceuticals Limited on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: J. B. Chemicals and Pharmaceuticals Limited
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Unique Pharmaceutical Laboratories, a human finished drug manufacturer in Bharuch, Gujarat, India, revealed significant deficiencies in their quality control unit. The firm failed to fully follow responsibilities and procedures, specifically regarding the accuracy of trend reports, the thoroughness of investigations, the detail in training records, and the definition of 'incidence' in their procedures. These issues indicate a lack of robust quality system oversight.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/j-b-chemicals-and-pharmaceuticals-limited/d77ff966-bfe4-483b-8ca9-723a59fcaba5

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1