Shocking Conditions at Indian pharmaceutical Manufacturer

The FDA inspection of an Indian manufacturer, which took place in December 2024, revealed serious violations of GMP requirements, in particular unsustainable hygienic conditions in the production and storage rooms. The FDA writes in the introduction that the manufacturer of OTC and homeopathic medicinal products had initially not responded to the inspection findings (Form 483), although the FDA had contacted the manufacturer several times. It was not until the FDA stopped a drug shipment at the border in March that the manufacturer requested a 90-day extension to respond to the FDA 483 form.

Unacceptable hygiene deficiencies

The FDA's list of shocking manufacturing conditions in the Warning Letter makes impressive reading. Among other things, the inspectors found

• Live rodents and birds in storage areas for finished drug products and packaging materials 
• Animal faeces and feathers on walls, floors and materials 
• Black, mould-like deposits on ceilings above production equipment and on walls near open tanks and filling lines 
• Insects in production areas 
• Stray dogs near open access doors 
• Production materials in dirty containers stored outdoors

These conditions demonstrate a complete failure of basic hygiene standards and pose a significant risk to drug safety. The FDA requires a comprehensive remediation plan, measures for technical and organisational control of the facilities as well as procedures for pest control and maintenance. 

GMP violations in material management

The Indian manufacturer did not test incoming materials for identity, relied solely on unverified CoAs from suppliers and did not operate a quarantine or release system. In addition, a critical raw material was used that was known to have been supplied with incorrect labelling - yet no identity testing was performed.
The FDA requires a complete reassessment of the material system and evidence of appropriate quality testing (chemical and microbiological) as well as a requirement for identity testing of each batch. In addition, a retrospective risk assessment is to be carried out for affected batches. 

Inadequate quality system

According to the FDA, the company's quality department showed serious weaknesses. It lacked basic SOPs (e.g. for deviations, cleaning, employee training), there was no process validation, no complete batch documentation, no adequate sampling and testing plans and no qualified cleaning procedures. The FDA requires a complete remediation programme to restore GMP compliance, including process validation and qualification of all equipment.

Recall and import ban

Due to the violations and the company's lack of response to official enquiries, a recall of the products was initiated by the US distributor. In addition, the FDA placed the company on Import Alert 66-40 on 31 March 2025 - all of the company's products may no longer be imported into the USA until further notice.

The detailed Warning Letter to the Indian manufacturer can be found on the FDA website.