# FDA 483 - UMED PHARMA LAB PRIVATE LIMITED - Unknown Date

Source: https://www.keypedia.com/records/483/umed-pharma-lab-private-limited/3060f81c-1a6c-4aa8-9513-e174d3279f8c

> FDA 483 for UMED PHARMA LAB PRIVATE LIMITED on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UMED PHARMA LAB PRIVATE LIMITED
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of UMED Pharma Lab Private Limited, a contract testing laboratory in Telangana State, India, revealed significant deficiencies in computer system controls and laboratory procedures. Observations included inadequate management of analytical instrument methods and microbiology equipment audit trails, leading to data integrity concerns and unaddressed alarm conditions. Additionally, the firm lacked scientifically sound test procedures, allowing critical equipment like incubators to operate out of range without proper justification or established corrective action protocols.

## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.keypedia.com/companies/umed-pharma-lab-private-limited/fe1fc778-e68b-488f-b9c9-d3f99272f907

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