FDA Issues Warning Letter to Healwell Homeo for Severe GMP Violations

Following a December 2024 inspection, the FDA uncovered serious GMP violations at Indian firm Healwell Homeo Pvt. Ltd., including alarming hygiene failures. Despite multiple follow-ups, the manufacturer failed to respond to Form 483 until March 2025, when a shipment was halted at the U.S. border.

Inspectors observed live rodents, birds, faeces, mold, insects, and stray dogs in production and storage areas, along with outdoor-stored drug materials in filthy containers. The firm also neglected raw material identity testing, relied on unverified Certificates of Analysis (CoAs), and lacked a proper quarantine system.

The FDA cited major deficiencies in quality systems: no SOPs for cleaning or training, incomplete batch records, no equipment validation, and inadequate sampling. The agency demands a full remediation plan, including pest control, material testing, and system-wide reassessment.

Due to noncompliance, a U.S. recall was initiated and the firm was placed on Import Alert 66-40, blocking its products from entering the country.

23-07-2025