Piramal Pharma Gets FDA Form-483 for Lexington Unit
Piramal Pharma's Lexington, Kentucky facility received a US FDA Form-483 following a Good Manufacturing Practices (GMP) inspection. The inspection resulted in four regulatory observations classified as Voluntary Action Indicated (VAI), focusing on procedural enhancements. The company is preparing a detailed response to address all observations within the stipulated regulatory timelines, emphasizing its commitment to maintaining high compliance standards.
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Piramal Pharma has received a US FDA Form-483 for its Lexington facility following a Good Manufacturing Practices (GMP) inspection. The pharmaceutical company disclosed that the inspection identified four regulatory observations that will be classified as VAI (Voluntary Action Indicated).
FDA Inspection Details
The US FDA conducted a comprehensive GMP inspection at Piramal Pharma's Lexington facility in Kentucky, USA. At the conclusion of the inspection, the regulatory authority issued Form-483 documenting four observations related to enhancement in procedures.
| Inspection Parameter | Details |
|---|---|
| Facility Location | Lexington, Kentucky, USA |
| Inspection Type | Good Manufacturing Practices (GMP) |
| Issues Identified | Four observations |
| Classification | VAI (Voluntary Action Indicated) |
| Regulatory Document | US FDA Form-483 |
Company Response and Compliance
Piramal Pharma has confirmed that it is preparing a detailed response to address all observations identified during the inspection. The company stated it will submit this comprehensive response to the US FDA within the stipulated regulatory timelines. The observations are specifically related to procedural enhancements rather than critical manufacturing deficiencies.
Regulatory Classification
The VAI (Voluntary Action Indicated) classification indicates that the FDA found objectionable conditions during the inspection, but the agency is not prepared to take or recommend any administrative or regulatory action. This classification is less severe than an Official Action Indicated (OAI) status, which would require more immediate and stringent corrective measures.
Commitment to Standards
The company emphasized its commitment to maintaining the highest standards of compliance and stated it will work closely with the FDA to comprehensively address all observations. This approach demonstrates Piramal Pharma's dedication to regulatory compliance and quality manufacturing standards at its US operations.
Historical Stock Returns for Piramal Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +1.55% | -3.00% | -10.83% | -12.74% | -30.72% | -5.98% |
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