The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations.
FDA notes that the company, which manufactures sterile eye and skin washes, documented "numerous leaking containers and other bottle formation defects" and subsequently received consumer complaints of leaking containers after adjusting its equipment and resuming production.
"In addition, you found numerous critical container-closure defects, including leaking products, during media fills studies. Container integrity is imperative to ensure sterility of ophthalmic drug products. The lack of assurance that your [redacted] equipment consistently manufactures an integral container-closure system diminishes confidence in the sterility of your marketed products," FDA said.
In addition, during FDA’s inspection, the company acknowledged its failure to validate its process prior to distributing drugs.
"It is essential that your firm improves your process design and control to correct the root causes of your recurring container-closure integrity defects. Without such remediation, successful process performance qualification studies alone are insufficient to demonstrate that your process is truly capable of a continuing state of control. In your response, provide an analysis of the root causes of in-process integrity defects and container-closure defects affecting distributed products," FDA said.
The agency also said the company product labels for its "Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct" make claims that would mean the products are drugs.
"Specifically, these products are intended as eyewashes. OTC drug products intended as eyewashes, such as Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct, are subject to the final monograph for Ophthalmic Drug Products for Over-the-Counter Use, see 21 CFR Part 349," FDA noted.
"However, these products are not labeled or formulated in accordance with this final monograph. While the labeled indications for Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct state that the products are intended for flushing the eye, the product names ‘Buffered Eye & Skin’ suggest that the products are intended for flushing the eye and skin. However, this intended use (e.g. flushing the skin) is not a permitted indication in the final monograph for eyewash drug product."
Opto-Pharm Pte Ltd. 3/16/17