Wanbury Ltd Completes USFDA Inspection at Facility, Issues Form 483 with Six Observations
Wanbury Limited has completed a routine Good Manufacturing Practices (cGMP) inspection by the United States Food and Drug Administration (USFDA) conducted at its facility in Tanuku. The company confirmed that the inspection took place between July 13, 2026, and July 17, 2026, at the Tanuku facility located in West Godavari District, Andhra Pradesh.Following the conclusion of the USFDA routine cGMP inspection, the USFDA issued a Form 483 detailing six observations. The company confirmed that it will respond to these observations within the stipulated timeframe.
The details regarding the action initiated by the USFDA and the associated outcomes have been reviewed, and Wanbury Limited has assessed the potential impact of the findings. A preliminary assessment indicates that all observed matters are addressable through appropriate supporting documentation, technical justification, procedural enhancements, and corrective actions.
Wanbury Limited stated that it does not anticipate any material impact on its manufacturing operations or exports to the United States and other international markets arising from this inspection. The company remains committed to maintaining the highest standards of quality and compliance with current Good Manufacturing Practices (cGMP).
Key details regarding the USFDA action and the company's assessment are summarized below:
| Aspect | Details |
|---|---|
| Authority | United States Food and Drug Administration (USFDA), USA. |
| Inspection Period | July 13, 2026, to July 17, 2026 |
| Outcome of Inspection | USFDA issued Form 483 with six observations. |
| Date of Communication | July 17, 2026 |
| Impact Assessment | The company does not expect any material impact on its operations or financial performance and views the observations as addressable through corrective actions and documentation. |
WANBURY Stock Price Movement
Wanbury Limited shares slipped today, settling at ₹330.65 after shedding 2.25% from the previous close. The stock traded within a tight intraday range, hitting a low of ₹321.95 and registering a volume of 586,287 shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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