# FDA 483 - Dr Reddy's Laboratories Limited - January 15, 2019

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited/d1c86a41-917f-4a9d-90f3-54075b6ca07e

> FDA 483 for Dr Reddy's Laboratories Limited on January 15, 2019. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr Reddy's Laboratories Limited
- Inspection Date: 2019-01-15
- Product Type: Biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA Form 483 details observations from an inspection, highlighting several deficiencies in quality control and manufacturing processes.

**Key Violations and Observations:**

*   **Inadequate Investigations:**
    *   Failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results for stability batches, specifically regarding API impurity levels.
    *   Investigation OOS 310013508 for OOS tablet results was not thorough, failing to confirm the use of tubes as a root cause and not evaluating why a concurrently prepared sample from another lot did not detect the impurity.
    *   Retesting after invalidating OOS results was performed on a single sample rather than the required number per SOP GQA035.
    *   Investigation of complaint 200217023 for a released batch did not extend to other distributed batches of the same product or include analytical testing of returned or reserve samples.
    *   Investigation OOS 310013534 for an OOS tablet assay did not expand to include prior batches, despite hypotheses of analyst error or inappropriate sampling.

*   **Data Integrity and Computer Controls:**
    *   Inadequate controls over computer systems to ensure changes to master records are made only by authorized personnel.
    *   Instrument PR186, used for in-process testing, uses a common password, allows operators to change time/date,

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited/97f3d461-62f0-4198-9e9d-7f7c7d43af86

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6