# FDA 483 - Invitron Advanced Analytics Private Limited - February 02, 2023

Source: https://www.globalkeysolutions.net/records/483/invitron-advanced-analytics-private-limited/7dd18f8b-e251-4dd2-bb85-cb217e7748e8

> FDA 483 for Invitron Advanced Analytics Private Limited on February 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Invitron Advanced Analytics Private Limited
- Inspection Date: 2023-02-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Invitron Advanced Analytics Private Limited's Control Testing Laboratory in Hyderabad, India, identified significant deficiencies in laboratory records. The firm failed to maintain complete data from electronic audit trails and did not adequately investigate repeated system errors from its Karl-Fischer titrator. These issues raise concerns regarding data integrity and the effectiveness of the firm's quality control processes.

## Related Officers

- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.globalkeysolutions.net/companies/invitron-advanced-analytics-private-limited/7ac8c888-1e1b-497a-be74-8f189f6489ce

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