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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.

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More from Compliance

Over The Counter: Why OTC Firms Should Care About Rx Advertising, With AdverCheck’s James Walmsley

 
• By David Ridley

HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.

ASA Files: ACME Vapes Case Shows Marketers Must ‘Know Their Audience’

 
• By David Ridley

A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 
• By Malcolm Spicer

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Perrigo’s Formula To Drive Earnings Rebound Swings On Further Formula Business Recovery

 
• By Malcolm Spicer

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

More from Policy & Regulation

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.