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US FDA Inspectors See Cloudy GMP Compliance At OTC Ophthalmic Drug Manufacturers

 
• By Malcolm Spicer

Agency warns two drug firms providing OTC eye drops about failing to maintain sanitary conditions after early in 2023 announcing Indian firm Global Pharma Healthcare made artificial tear products recalled due to potential infection from bacterial contamination not previously seen in US.

• Source: Shutterstock

Regulators’ concerns about potential contamination of OTC eye care products due to manufacturing-quality deficiencies aren’t limited to an Indian firm linked to artificial tear drops found to contain bacterial contamination not previously seen in the US.

The Food and Drug Administration has warned two US drug firms providing OTC eye drops about failing to maintain sanitary conditions since announcing early in 2023 that Indian firm Global Pharma Healthcare Private Ltd

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