Inspection Details
- Authority: United States Food and Drug Administration (USFDA)
- Facility Inspected: Unit VII, Analytical Services Division of Shilpa Medicare Limited
- Location: Plot No.79, Road No. 15, Survey No.125, IDA Mallapur, Nacharam, Uppal Mandal, Medchal, Malkajgiri Dist. – 500076 Hyderabad, Telangana
- Inspection Type: Surveillance Inspection (SI)
- Inspection Period: 16 September 2026 to 18 September 2026
- Conclusion Date: 18 September 2026
Inspection Outcome
The USFDA issued one observation at the conclusion of the inspection. The observation was:
- Procedural in nature
- Not a repeat observation
- Not related to data integrity
Company Response
The company will submit a comprehensive response to the USFDA within the stipulated timeline. The response will address the observation with appropriate corrective and preventive actions. The company stated its commitment to maintaining the highest standards of quality and compliance across all operations.
Financial and Operational Impact
The company does not expect this development to have any material impact on:
- Current business operations
- Existing supplies from this facility
Additional Information
The disclosure is also available on the company's website at www.vbshilpa.com.