Mylan Laboratories Limited – FDA 483, Sep 14, 2016

This FDA Form 483 document outlines several observations made during an inspection, indicating deficiencies in the facility's quality system and manufacturing controls.

**Key Observations:**

1. **Test Method Validation:** The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented. This indicates a lack of validation for critical analytical procedures, potentially impacting the reliability of product testing.

2. **Batch Failure Investigations:** There is a failure to thoroughly review batch failures or any of their components that do not meet specifications, regardless of whether the batch has been distributed. This suggests inadequate investigation processes for non-conforming products.

3. **Laboratory Controls:** Laboratory controls lack scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. These are necessary to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to identity, strength, quality, and purity standards.

4. **Computer System Controls:** Appropriate controls are not exercised over computers or related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel. This points to potential vulnerabilities in data integrity and unauthorized access.

5. **Drug Complaint Investigations:** Written records of drug complaint investigations do not include the findings of the investigation and the follow-up. This indicates incomplete documentation for customer complaints, hindering effective resolution and trend analysis.

6. **Equipment Cleaning and Maintenance:** Equipment and