Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

By Gareth Macdonald contact

- Last updated on GMT

Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

Related tags: Food and drug administration, Pharmaceutical drug

The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.

Cheryl was banned​ from supplying drugs to the US last week when the US Food and Drug Administration (FDA) added the firm to its “Red List” of companies that have refused to allow agency staff to assess manufacturing operations.

The FDA policy states that: "“The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions​.”

Cheryl makes creams, ointments, liquid pharmaceutical, antiseptic products and gels at the Navi Mumbai facility. The plant was established in 2004.

According to the FDA "Products imported from the firms listed on the Red List to this import alert should remain subject to detention without physical examination until an FDA inspection is completed. Firms may provide copies of inspection reports for inspections performed by third parties only to assist FDA in prioritizing inspection requests​."

Related topics: Markets & Regulations, QA/QC, Regulations

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