FDA: Global Pharma’s eye drops contaminated with 'filth' while Amazon made unapproved claims for eye drops
The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have been linked to an outbreak of bacterial infections resulting in consumer injury, blindness, and at least three deaths. In a related enforcement action, FDA also rebuked Amazon for making unapproved drug claims.FDA’s list of contaminated eye drops continues to grow, signaling that the problem is not going away anytime soon. The agency on 16 November updated its list of OTC products consumers should not buy or use due to the risk of infection which could lead to full or partial vision loss.
The agency has responded to the situation by issuing recent guidance recommending a battery of studies that manufacturers can use to assess the quality of topical ophthalmic drugs (RELATED: FDA issues guidance on assessing quality of topical ophthalmic drugs, Regulatory focus 16 October 2023).
Global Pharma eye drops linked to outbreak
As explained in the Global Pharma warning letter, FDA began collaborating with the US Center for Disease Control and Prevention (CDC) in December 2023 to investigate a multistate outbreak of antibiotic-resistant Pseudomonas aeruginosa infections that affected over 80 patients, leading to four deaths and 14 cases of vision loss.
As part of this investigation, FDA targeted Global Pharma’s site in India and collected product samples of the artificial tears and eye ointment batches during a late February inspection. The sampled drugs included EZRICARE artificial tears, Delsam Pharma’s artificial tears and Delsam Pharma’s artificial eye ointment.
FDA’s testing revealed that 18 batches of artificial tears were non-sterile, and the ointment was also found non-sterile as well. Further, the firm’s ophthalmic drug products “were intrinsically contaminated with microorganisms.” Pseudomonas aeruginosa isolates from three different batches of Artificial Tears samples were found to be close genetic matches to over 85 clinical isolates associated with this outbreak.
FDA said that “these test results demonstrate that these lots are adulterated under section 501(a)(1) of the FD&C Act, in that they have been contaminated with filth, and rendered injurious to health.”
The agency further noted that “significantly, the pervasive contamination of your drug products, as indicated by FDA sample results, also demonstrates that all drugs made at your facility are adulterated under section 501(a)(2)(A) of the FD&C Act as they have been manufactured under insanitary conditions.
FDA investigators found a multitude of GMP violations, including a failure to clean equipment used to aseptically produce artificial tears. Investigators observed “visible grease-like residue on product contact surfaces of your filling machine after they had been cleaned.”
The company also earned failing grades for its environmental monitoring (EM) program where non-viable air samples were not collected inside the Grade A filling zone or the Grade B area during active filling. In addition, the company lacked studies to demonstrate that disinfectants would not interfere with swabs used in viable surface monitoring. The firm also lacked identification data on isolates recovered from EM and personnel monitoring (PM) sampling.
The company also “failed to perform adequate batch release to ensure the acceptability of all batches of Artificial Tears, prior to release for the US market.”
The firm also allowed the use of pre-filled batch release documents, a practice that is deemed “unacceptable” to the agency.
In addition, FDA found that cleanroom operators “lacked adequate gowning and qualification for performing aseptic operations” therefore putting products at high risk for contamination. Operators were not wearing sterile goggles and therefore were exposing skin during aseptic operations. In addition, “cleanroom garments were stained, worn out, and stored improperly.”
The company initiated a voluntary recall on 24 February, a notification warning consumers to stop using sterile eye drops made by Global Pharmaceutical Healthcare because of microbial contamination.
FDA states that “there is a reasonable probability that instillation of a bacterially contaminated eye product into the eye may cause a range of ocular infections, from minor to serious, vision-threatening infections which could progress in some cases to life-threatening systemic bacterial infection,” states the warning letter.
The firm is no longer supplying these products to the US market.
FDA told the company that “given the egregious violations of CGMP at your facility, if you plan to resume drug manufacturing operations for the U.S. market, decide to transfer your ownership, contract out any processes, or move to a new location, notify this office.”
Amazon blasted for marketing unapproved eye drops
FDA also expressed concern about the unapproved OTC eye drops being sold by Amazon.com in a 13 November warning letter Amazon and its CEO Andrew Jassy. Affected products included Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops.
These products claim to treat pink eye, relieve dryness, and provide temporary relief for minor irritations to the eye, according to their listings on Amazon websites.
FDA told Amazon that marketing eye drops for unapproved claims are “especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”
Amazon has 15 days to respond to the violations and failure to address issues identified in the warning letter may result in a seizure or injunction.
Kilitch Healthcare Industry Voluntary Recalls
In a related development, Kilitch Healthcare India Limited announced on 16 November a voluntary nationwide recall of 26 OTC lubricant eye drops for safety reasons. FDA announced that “there is a potential risk of eye infections or related harm for consumers who use their products.
These products were distributed to national wholesalers and retailers including Target, Rite Aid, and CVS via the distributor, Velocity Pharma LLC.
Global Pharma, Amazon
