# FDA 483 - Sidmak Laboratories India Pvt Ltd - May 13, 2023

Source: https://www.globalkeysolutions.net/records/483/sidmak-laboratories-india-pvt-ltd/801b0c65-5ca0-4cc6-8dea-f665babb6b3d

> FDA 483 for Sidmak Laboratories India Pvt Ltd on May 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sidmak Laboratories India Pvt Ltd
- Inspection Date: 2023-05-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sidmak Laboratories India Pvt. Ltd. in Dehradun, India, received a Form FDA 483 citing significant deficiencies during an inspection. Observations included inadequate equipment qualification and calibration practices, particularly concerning performance qualification and the use of improvised tools for calibration. Furthermore, the firm demonstrated a lack of appropriate controls for computer-acquired data, such as missing audit trails, shared user credentials, and insufficient electronic data backup, alongside a failure to properly validate an analytical method for drug products.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/sidmak-laboratories-india-pvt-ltd/2728534a-42a6-48f9-af65-6e6c302663a9

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