# FDA 483 - Mylan Laboratories Limited - June 26, 2024

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/8d80a740-a39c-41f1-a0fe-76664c670680

> FDA 483 for Mylan Laboratories Limited on June 26, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2024-06-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: During an inspection from June 14-26, 2024, at Mylan Laboratories Limited (FEI 3010453141), a drug products manufacturer in Pithampur, India, the FDA observed several violations. Mr. Pramod Kumar Singh, Head of Operations - India and Africa, was issued the Form 483.

**Key Observations:**

*   **Equipment Cleaning Deficiencies:** Non-dedicated equipment, including a HEPA filter chamber and duct in Block, used for manufacturing Tablets mg, showed white to off-white materials despite being in "Type A cleaning status." This indicates inadequate cleaning intervals to prevent contamination affecting drug product safety, identity, strength, quality, or purity.
*   **Inadequate Quality Unit Procedures:** The Quality Unit failed to provide scientific justification for sampling only "good tablets" after a rejected tablet was identified outside the acceptable weight range, as per SOP-000464236. This raises concerns about the reliability of quality control for variable batch sizes.
*   **Insufficient OOS Investigations:** Investigations into out-of-specification (OOS) results lacked scientific rationale for root cause determinations. An example cited was Laboratory Investigation PR ID: 3455440 (opened 28-Mar-2024) for Tablets, where OOS/OOT results were observed for Dissolution profile tests at 3 and 1

## Related Documents

- [483 - 2024-06-26](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/87897492-4940-476d-9c33-d87c45e038b2)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.globalkeysolutions.net/companies/mylan-laboratories-limited/b7da9cbd-d5e3-417f-a485-f9e38852b256

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