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US FDA source recordWL · Warning Letter

Gopaldas Visram & Co., Ltd. — FDA Warning Letter

Issued to Gopaldas Visram & Co., Ltd.. Serious post-market compliance violation.

Issued

June 2, 2026

Product

CGMP/OTC Finished Pharmaceuticals/Adulterated

Company

Gopaldas Visram & Co., Ltd.

Review center

CDER

Stage

Final Decision

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Why did Gopaldas Visram & Co., Ltd. receive an FDA warning letter?

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Source facts

FDA issued a warning letter to Gopaldas Visram & Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

Key details in this letter

  • 1Subject: CGMP/OTC Finished Pharmaceuticals/Adulterated.
  • 2Issuing office: Center for Drug Evaluation and Research (CDER).
  • 3Manufacturing and CGMP controls: 1 source-text match.
  • 4No closeout letter was listed in the source metadata at refresh time.
Manufacturing and CGMP controls

Suggested next step

Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAHTMLUpdated Jul 30, 2026

FDA source document

Read the full FDA warning letter

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Common questions about the Gopaldas Visram & Co., Ltd. warning letter

What does this warning letter mean for Gopaldas Visram & Co., Ltd.?

Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on June 2, 2026.

What happens after an FDA warning letter?

The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.