# FDA 483 - Bal Pharma Limited- Unit 2 - November 16, 2018

Source: https://www.globalkeysolutions.net/records/483/bal-pharma-limited-unit-2/92b05b98-4e0c-427e-ae34-f47fc2c93665

> FDA 483 for Bal Pharma Limited- Unit 2 on November 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bal Pharma Limited- Unit 2
- Inspection Date: 2018-11-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Bal Pharma Limited, a manufacturer in Bangalore, India, was inspected and cited for significant deficiencies across its quality control and production processes. Observations included a lack of scientific justification for intermediate retest dates, failure to follow quality unit procedures for record documentation, inadequate evaluation of packaging material suppliers, and missing label specimens in batch records. The inspection revealed systemic issues in maintaining proper controls and documentation for manufacturing and packaging materials.

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

Company: https://www.globalkeysolutions.net/companies/bal-pharma-limited-unit-2/7c97d68d-2f80-41de-92f3-d97ef6068792

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd