# FDA 483 - Vital Laboratories Pvt Ltd Plant II - September 01, 2018

Source: https://www.keypedia.com/records/483/vital-laboratories-pvt-ltd-plant-ii/b3e0ff39-918d-4a8b-942b-5c78f9dbc713

> FDA 483 for Vital Laboratories Pvt Ltd Plant II on September 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vital Laboratories Pvt Ltd Plant II
- Inspection Date: 2018-09-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Vital Laboratories Pvt. Ltd. received an FDA Form 483 following an inspection of their API manufacturing facility in Vapi, Gujarat, India, conducted from August 28 to September 1, 2018. The inspection identified several critical deficiencies, highlighting a lack of robust quality system controls and adherence to Good Manufacturing Practices.

Key observations included a repeat violation for incomplete batch production records, with missing signatures, dates, and essential process details. The firm also failed to thoroughly investigate and document customer complaints and unplanned deviations, frequently lacking root cause analysis and comprehensive corrective actions. A significant systemic issue was the absence of trending for common deviations, such as recurring column errors.

Further issues noted were inadequate facility controls, evidenced by the presence of food and drinks in Class D manufacturing areas, and the use of unapproved labeling on materials. Documentation practices were substandard, with unapproved scrap paper utilized for tracking pending analyses. Several Standard Operating Procedures were found to be inadequate, affecting areas like computer system user policies, incident reporting, and environmental monitoring. Additionally, the Control Sample Room exhibited temperature and humidity conditions outside specified requirements. Vital Laboratories is required to address these observations by implementing comprehensive corrective and preventative actions to ensure compliance with regulatory standards.

## Related Documents

- [WARNING_LETTER - 2017-04-06](https://www.keypedia.com/records/warning_letter/vital-laboratories-pvt-ltd-plant-ii/f662890f-f613-4bee-b298-88c9f7f5ac5e)
- [483 - Unknown Date](https://www.keypedia.com/records/483/vital-laboratories-pvt-ltd-plant-ii/8112808c-9f62-4c56-acf4-8ca1c46cd507)

## Related Officers

- [Technical Director](https://www.keypedia.com/people/anil-b-ghogare/4bff71c3-efd9-4878-841f-dac4685d6588)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/vital-laboratories-pvt-ltd-plant-ii/d1a66873-98f5-46be-ab77-4f873950762e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8