# FDA 483 - Dr. Reddy's Laboratories Ltd. - October 29, 2021

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd/0c0f4281-c7bc-48e4-821e-60a67eef0c14

> FDA 483 for Dr. Reddy's Laboratories Ltd. on October 29, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd.
- Inspection Date: 2021-10-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 inspection identified significant deficiencies at the facility, impacting its quality control, laboratory operations, aseptic processing, and investigation procedures.

**Observation 1** highlights that the quality control unit's responsibilities and procedures are not fully followed. Specifically, the change control procedure lacks instructions for protocol changes, leading to post-execution revisions of submission batch protocols without proper documentation. Incident handling procedures are also not followed, as demonstrated by a delayed initiation of an incident for major visual defects and the separation of reports for a single incident number without SAP system reference for minor defects. Additionally, a pharmacopoeia update procedure was not followed, resulting in the use of an outdated test method for drug substance release.

**Observation 2** details that laboratory controls lack scientifically sound specifications, sampling plans, and test procedures for drug substances and products. Examples include an unjustified change in viscosity specification due to equipment issues, an unvalidated and scientifically unsound particle matter test method, and a related substances test method with unsupported sample temperature and system suitability requirements.

**Observation 3** indicates deficiencies in the environmental monitoring system for aseptic processing areas. The firm failed to provide scientific justification for viable monitoring site selection, particularly for high-risk areas and difficult-to-clean surfaces. There was also a failure to perform risk evaluation for not conducting viable personnel monitoring for aseptic filling operators in the Grade C area, despite recoveries of atypical and opportunistic pathogens.

**Observation 4** states that procedures to prevent microbiological

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## Related Officers

- [Rita Kabaso](https://www.keypedia.com/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)
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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-ltd/3c6515a2-e42e-4803-ab0c-43955c67ee4f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c