Eye Drop Company Faces FDA Scrutiny Again Over Unapproved Products

眼药水公司因未经批准的产品再次面临FDA审查

September 19, 2024

2024年9月19日

The FDA has issued a warning letter to the Regenerative Processing Plant, manufacturer of Regener-Eyes Pro and Lite eye drops, for marketing unapproved products claiming to treat dry eyes. These products, which contain amniotic fluid, raise significant safety concerns. The FDA flagged the company for several violations of current good manufacturing practices (CGMP), including failure to validate aseptic practices and inadequate environmental monitoring..

美国食品和药物管理局（FDA）已向再生加工厂（Regener Eyes Pro和Lite滴眼液的制造商）发出警告信，要求其销售声称可治疗干眼症的未经批准产品。这些含有羊水的产品引起了严重的安全问题。美国食品和药物管理局（FDA）对该公司多次违反现行良好生产规范（CGMP）的行为进行了标记，包括未能验证无菌规范和环境监测不足。。

In 2021, Regener-Eyes received a similar warning related to its use of amniotic fluid. Despite assurances that production had ceased, the FDA inspection revealed continued shipments of amniotic fluid, linking the product codes to those produced after June 2021.

2021年，Regener Eyes收到了与使用羊水有关的类似警告。尽管保证停止生产，但FDA检查显示羊水仍在继续运输，将产品代码与2021年6月后生产的产品代码联系起来。

Key Safety Concerns

关键安全问题

The FDA cited major concerns regarding the company’s eye drops, which are formulated with sodium chloride, an ingredient that is not permitted in over-the-counter lubricants. The labeling of the products was also deemed misleading, with sodium chloride incorrectly listed as an inactive ingredient when, in fact, it plays an active role in treating conditions.

美国食品和药物管理局（FDA）对该公司的滴眼液表示担忧，该滴眼液是用氯化钠配制的，氯化钠是非处方润滑剂中不允许使用的成分。产品的标签也被认为具有误导性，氯化钠被错误地列为非活性成分，而事实上，它在治疗疾病中起着积极的作用。

Additionally, the drops were packaged in multi-dose vials without preservatives, leaving the product vulnerable to contamination and posing risks to consumers. The absence of a backflow prevention mechanism in the packaging further exacerbates the risk of bacterial or fungal growth..

此外，滴剂被包装在不含防腐剂的多剂量小瓶中，使产品容易受到污染，并对消费者构成风险。包装中缺乏防回流机制，进一步加剧了细菌或真菌生长的风险。。

Risks of Amniotic Fluid Use

使用羊水的风险

Experts, including Dr. Sandra Brown, MD, from Cabarrus Eye Center and a board member of the Dry Eye Foundation, have raised alarms over the use of amniotic fluid in eye drops. She noted that without established quality control measures, the fluid could be contaminated with bacteria or viruses, including sexually transmitted diseases.

包括卡巴鲁斯眼科中心医学博士桑德拉·布朗博士和干眼症基金会董事会成员在内的专家对滴眼液中使用羊水提出了警告。她指出，如果没有既定的质量控制措施，液体可能会被细菌或病毒污染，包括性传播疾病。

Proteins in the fluid degrade quickly when stored at room temperature, rendering them ineffective within hours..

液体中的蛋白质在室温下储存时会迅速降解，使其在数小时内失效。。

A Broader Issue with Unregulated Eye Drops

不受管制的滴眼液的一个更广泛的问题

This case is part of a larger pattern of FDA oversight of problematic eye drops, following issues with other products such as EzriCare Artificial Tears, which were linked to bacterial outbreaks earlier in 2023. Paul Knoepfler, PhD, a stem cell expert, remarked on the FDA’s slow response to unapproved biological drugs, noting that the agency often takes incremental steps, such as untitled and warning letters, which can extend the period of consumer risk..

这起案件是美国食品和药物管理局（FDA）对有问题的滴眼液进行监督的更大模式的一部分，此前其他产品（如EzriCare人工泪液）出现了问题，这些产品与2023年初的细菌爆发有关。干细胞专家保罗·克诺普勒（PaulKnoepfler）博士评论说，FDA对未经批准的生物药物反应缓慢，并指出该机构通常会采取渐进措施，例如无标题和警告信，这可能会延长消费者的风险期。。

The FDA's inspection of the Regenerative Processing Plant found three main violations: manufacturing unapproved new drugs, misbranding, and several CGMP violations. This is not the first time the FDA has warned manufacturers of eye drops over bacterial and fungal contamination risks, as seen with recalls of several products sold at major retailers such as CVS, Rite Aid, and Target..

FDA对再生加工厂的检查发现了三个主要违规行为：生产未经批准的新药、贴错标签和几起违反CGMP的行为。这不是FDA第一次就细菌和真菌污染风险向滴眼液制造商发出警告，正如CVS、Rite Aid和Target等主要零售商召回的几种产品所见。。

FDA Continues to Monitor Eye Drop Manufacturers

FDA继续监测滴眼液制造商

The FDA’s ongoing scrutiny of eye care products aims to address the growing concern over the safety and quality of over-the-counter eye drops, both domestically and internationally. Manufacturers are urged to adhere to CGMP and ensure proper labeling and packaging to prevent harm to consumers.

FDA正在对眼部护理产品进行审查，旨在解决国内外对非处方滴眼液安全性和质量的日益担忧。敦促制造商遵守CGMP，并确保正确的标签和包装，以防止对消费者造成伤害。

For now, the FDA has recommended that Regenerative Processing Plant bring its products into compliance and warned consumers about the potential risks of using unapproved eye drops.

目前，FDA建议再生加工厂将其产品纳入法规，并警告消费者使用未经批准的滴眼液的潜在风险。