# FDA 483 - Lupin Limited - January 25, 2019

Source: https://www.keypedia.com/records/483/lupin-limited/70b65220-35c3-48b6-89b1-0be80e795312

> FDA 483 for Lupin Limited on January 25, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2019-01-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection, primarily concerning quality control, data integrity, and personnel training.

**Observation 1** highlights a failure to thoroughly review unexplained discrepancies and Out-of-Specification (OOS) results. This includes:
*   **Moxifloxacin Ophthalmic Solution USP 0.5% (Batch H800393):** An OOS for Related Substances (impurity exceeding specification) was identified. The impurity was re-categorized as (b)(4) formed due to (b)(4) on the product label. A health-hazard assessment, acknowledging (b)(4) as an eye irritant, was delayed. Deficiencies include failure to re-train analysts, unscientific justification for analyzing retention samples quarterly, and limited market action (recall only for OOS batch H800393 while other impacted batches remained on the market). A CAPA to develop an analytical method for (b)(4) on labels was closed by procuring new labels without (b)(4), without an in-house verification test or supplier audit. The R&D evaluation did not explain why only the OOS batch was impacted. No attempt was made to quantify (b)(4) on labels. A formal analytical method re-validation for (b)(4) in the finished product has not been performed, and a limit for (b)(4) is not established. The current shelf

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## Related Officers

- [Jogy George](https://www.keypedia.com/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
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Company: https://www.keypedia.com/companies/lupin-limited/8707ad63-3e60-4c11-9138-77be2a49865c

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