Warning Letter from FDA Pune Disclosed After SEBI Letter
The company disclosed a Directions and Warning Letter from the Food & Drug Administration, Pune dated 10.01.2025.
- Regulatory Authority
- Food & Drug Administration, Pune
- Warning Letter Date
- 10.01.2025
- Product Involved
- Propylene Glycol, technical grade
- Violation
- Contravention of Drugs and Cosmetics Act, 1940
- Action Taken
- Strict warning issued — no penalty, prosecution or adverse order
What was shared
The company intimated the exchanges about a Directions and Warning Letter issued by the Food & Drug Administration, Pune, dated 10.01.2025.
What happened
- The company sold a consignment of Propylene Glycol, technical grade, to a customer for industrial use only.
- Without the company's knowledge or consent, that customer resold the material to a third party, who used it for pharmaceutical purposes.
- Use of a technical-grade product in pharmaceutical applications was found to contravene the Drugs and Cosmetics Act, 1940 and Rules made thereunder.
- The competent authority accordingly issued a strict warning to the company.
Outcome
No penalty, prosecution or other adverse order was passed against the company. The company states there is no material impact on financials, operations or other activities.
Corrective steps stated
- Reviewed sales and documentation practices to prevent recurrence.
- Clearly stating the intended end-use on invoices and labels.
- Obtaining end-use declarations from customers.
Why disclosed now
The company was of the view that the letter did not fall within the events requiring disclosure under the relevant provision, and hence did not submit the disclosure earlier. On receipt of a SEBI letter dated 29th September 2026, it has now shared the disclosure.
How investors may read it
The regulatory action itself is limited to a warning with no monetary claim. However, the disclosure follows a SEBI communication about a letter received earlier, which points to a delay in reporting.
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