FDA 483 - Mylan Laboratories Limited - June 26, 2024

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