# FDA 483 - Aurobindo Pharma Limited - May 10, 2022

Source: https://www.keypedia.com/records/483/aurobindo-pharma-limited/32976071-2001-4f14-887c-76d96e0a30e8

> FDA 483 for Aurobindo Pharma Limited on May 10, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2022-05-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection.

**Observation 1** highlights inadequate investigations into unexplained discrepancies and out-of-specification (OOS) results. Investigations for OOS assay and dissolution in tablet batches, identifying lack of control over compression machine settings (e.g., compaction force) as a root cause, were not extended to other tablet products or historical data. This includes instances where increased compression force caused powder segregation, high compression force caused material segregation, low compaction force led to dissolution failures, and raw material issues impacted dissolution. Furthermore, investigations into cross-contamination in capsule manufacturing due to inadequate cleaning were insufficient, lacking analytical verification and broader equipment evaluation. Product Non-Conformance (PNC) investigations related to HPLC instrument failures and standard failures, leading to disregarded chromatography data, lacked identified corrective or preventive actions.

**Observation 2** notes the absence of written procedures for production and process controls to assure drug product quality. Critical parameters like compaction force, impacting batch variability, are not established in process validation studies for most tablet products. Tentative limits for compaction force in recent validations lack finalization and supporting analytical data, allowing operators to exceed them without investigation. A protocol to set limits using historical data has not resulted in established limits and does not require additional sampling or analytical data to confirm product quality at proposed ranges.

**Observation 3** indicates incomplete batch production and control records. Tablet compression machine rejection limits, set by supervisors and changeable during manufacturing, lack

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/aurobindo-pharma-limited/95bcc3b3-09a1-4249-af2f-5c83de789b76

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