# FDA 483 - Dr Reddy's Laboratories Limited - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/b5eeaff1-a473-4a99-98d0-5162cc8409bd

> FDA 483 for Dr Reddy's Laboratories Limited on December 08, 2023. Product: Other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dr Reddy's Laboratories Limited
- Inspection Date: 2023-12-08
- Product Type: Other
- Summary: This FDA Form 483 document details deficiencies observed during an inspection related to laboratory records, data integrity, and employee training.

**Facility and Operation Details:** The inspection pertains to a facility producing (b)(4) Injection and (b)(4) API. The firm conducted a sameness study for (b)(4) Injection to compare it to a Reference Listed Drug (RLD) using Circular Dichroism Spectropolarimeter (equipment ID: AA266) and Nuclear Magnetic Resonance Spectrometer (NMR, equipment ID: AA574).

**Violations and Observations:**
*   **Deficient Laboratory Records:** Laboratory records for the sameness study of (b)(4) Injection were found to be deficient, lacking complete and accurate data.
    *   **Omitted and Unreported Electronic Data:**
        *   An initial Circular Dichroism spectra scan for Test Drug batch (b)(4) on 11/25/2016, created at (b)(4), was omitted from analysis. A second scan was reported instead, and a temperature fluctuation incident was not investigated or reported to the agency.
        *   Circular Dichroism data for RLD batch #(b)(4) and Test Drug batch (b)(4) generated on 11/28-29/2016 was not reported and invalidated without scientific justification. A Laboratory Investigation Report (LIR-A-AD

## Related Documents

- [483 - 2023-12-08](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/fb32f529-19a9-4a4e-a007-4098699a5054)

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited/b8bf1054-aff5-4e43-8319-48f33c09d531