# FDA 483 - Vipor Chemicals Private Ltd. - February 21, 2018

Source: https://www.globalkeysolutions.net/records/483/vipor-chemicals-private-ltd/9d4041fa-0caa-4480-a86c-853981b8e791

> FDA 483 for Vipor Chemicals Private Ltd. on February 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vipor Chemicals Private Ltd.
- Inspection Date: 2018-02-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Vipor Chemicals Private Limited, an API manufacturer in Vadodara, India, was cited for numerous severe Good Manufacturing Practice (GMP) deficiencies during an FDA inspection. Key issues include a non-existent independent Quality Unit, widespread data integrity problems, inadequate personnel training, poorly maintained facilities and equipment, and a lack of validated processes and quality control procedures. These findings indicate a fundamental breakdown in the firm's quality system and its ability to ensure the quality, purity, and safety of its Active Pharmaceutical Ingredients.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/lillie-d-witcher/6e879b86-97a9-48a2-aac6-9f13443b0d17)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/vipor-chemicals-private-ltd/06b20324-3b25-49fc-aa44-209a524ddca7

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