# FDA 483 - Dr. Reddy's Laboratories Ltd. - April 28, 2017

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd/5cf54d6c-e53a-432a-b758-d78d80419fa9

> FDA 483 for Dr. Reddy's Laboratories Ltd. on April 28, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd.
- Inspection Date: 2017-04-28
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection, indicating significant issues with laboratory controls, data integrity, quality unit authority, personnel qualifications, and equipment maintenance.

Key violations include:
*   **Laboratory Controls:** Absence of scientifically sound sampling plans for in-process materials and drug products, leading to inadequate assurance of identity, strength, quality, and purity. Laboratory records are incomplete, lacking full data from testing.
*   **Data Integrity:** Backup data is not assured as exact, complete, or secure from alteration, erasure, or loss.
*   **Product Release:** Drug products are released for distribution without appropriate laboratory determination of conformance to final specifications.
*   **Quality Control Unit:** The quality control unit's responsibilities and procedures are not fully followed, and it lacks the authority to fully investigate errors.
*   **Equipment Maintenance:** Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment are not performed according to a written program.
*   **Personnel Qualifications:** Individuals supervising manufacturing and processing, as well as employees engaged in these activities, lack the necessary education, training, and experience to assure product safety, identity, strength, quality, and purity.
*   **Supplier Reliability:** The reliability of component suppliers' reports of analyses is deficient, with test results not appropriately validated at intervals.
*   **Reserve Samples:** Reserve samples are not visually examined annually for deterioration.

These observations suggest systemic failures in the

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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-ltd/5a4c4806-5444-4838-9cda-0b0da2f42221

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02