FDA inspection of Regener-Eyes manufacturing facility unveils significant violations

Findings from a recent FDA inspection report of Regener-Eyes’s manufacturing facility have uncovered a number of regulatory violations and potential contaminations.

Let’s start with this inspection.

Back in June 2023, the FDA conducted an inspection of Regener-Eyes’ Regenerative Processing Plant (RPP) LLC drug manufacturing facility for drug quality assurance located in Palm Harbor, Florida.

Was this the facility's first?

Nope. This was actually the fourth inspection conducted at this location.

Previous inspections were performed in 2015, 2017, and 2020 (with no violations or deficiencies observed).

Updated to add: These previous inspections conducted at the Palm Harbor, Florida, location were tissue processing inspections—not drug manufacturing inspections.

And the results?

Fast forward to December 2023, the agency posted a summary of its findings—which featured a slew of violations—that cumulatively led to the rating of “Official Action Indicated (OAI),” otherwise known as the worst overall outcome.

Talk about these violations.

Per the FDA’s Data Dashboard, 15 regulatory violations led to the following citations listed in the final inspection report:

• Manufacturing procedures were not in writing or fully followed.
• Buildings used for drug manufacturing/processing/packing not suitable for cleaning, maintenance, and proper operations.
• Deficient system for monitoring environmental conditions.
• Contamination prevention measures not followed on equipment and utensils
• No established written procedures for cleaning/sanitizing/maintaining equipment and utensils.
• No identification tests conducted on drugs already accepted based on the supplier’s analysis report.
• Container closure systems did not provide protection against possible anticipated storage and use which could cause deterioration or contamination of drug products.
• Lack of validation process to prevent microbiological contamination for supposed sterile drug products.
• No representation of samples taken for ensuring product conformity for each lot within each shipment of product containers.
• Stability testing results not used in determining appropriate storage conditions or expiration dates.
• No retention of reserve samples for drug products for 1 year following their respective expiration dates.
• Production records associated with each drug product batch were not maintained for at least one (1) year following their expiration date.
• Batch production and control records have no specific identification of each drug product batch produced.
• Failure to review unexplained discrepancies and a failure of drug product batches to meet any specifications (regardless of batch distribution).
• Deficient laboratory records with no complete record of all data obtained during testing.

Where can I find the full report?

The Dry Eye Foundation, a 501(c)(3) non-profit based in Poulsbo, Washington, actually obtained a copy via a Freedom of Information Act request for the FDA Form 483.

To note, an FDA Form 483 is issued to a company following an inspection of any observed conditions deemed in violation of federal guidelines. Click here to download it.

Also of interest: in response to the foundation’s report on this inspection, RPP’s official spokesperson told Glance that the information is “not an accurate representation of the observations. It is important to note: this group does not represent the FDA.”

So which products are produced at this plant?

• Regener-Eyes PRO eye drops
• Regener-Eyes LITE eye drops

Take note: both ophthalmic solutions are over-the-counter (OTC) products marketed as preservative-free lubricants intended to prevent further irritation or to relieve eye dryness.

What else?

Regener-Eyes’ product website includes the following claims regarding the products:

• Each batch of Regener-Eyes is tested to ensure quality, sterility, and safety
• Regener-Eyes is in compliance with all federal regulatory laws

Has the company responded yet?

Regarding the citations listed on the FDA Dashboard, the RPP spokesperson told Glance that, “The information on the FDA dashboard is obviously accurate.”

They further stated that, following the June 2023 inspection, “RPP spent the next 4 months completing the actions necessary to address the observations,” and, to date, have addressed all of the agency’s observations.

And what about the company’s flagship product, Regener-Eyes Ophthalmic Solution?

The solution, which is used in both Regener-Eyes PRO and LITE eye drops, is “in full compliance with the FDA,” the RPP spokesperson told Glance.

"It is important to note Regener-Eyes, LLC and Regener-Eyes Ophthalmic Solution eye drops were also audited and inspected more than 6 months ago,” they wrote. “The FDA found no [FDA Form] 483 observations or deficiencies in Regener-Eyes, LLC.”

Gotcha. Didn’t Regener-Eyes have a run-in with the FDA earlier this year?

Good memory! In April 2023, the agency issued a public safety notification that warned of potential safety concerns with the marketing and distribution of amniotic fluid eye drops that had not received pre-market review and approval.

Regener-Eyes, along with M2 Biologics LLC, received letters from the FDA with warnings (see our coverage here). At the time, Regener-Eyes (whose eye drops had previously secured an OTC drug indication) told Glance:

“The OTC Monograph was the subject of a final administrative order by the FDA, meaning that the non-prescription drug is generally recognized as safe and effective (GRASE) for its intended use."

Interesting… I feel like there’s been a whole lot of inspections this year.

In light of the seemingly endless number of eye drop warnings and recalls, it really does.

In fact, the FDA released a preliminary inspection report last month regarding a visit to the India-based manufacturer (Kilitch Healthcare) of those 27 eye drops the agency warned against using in October 2023.

Similar observations were noted, right down to a lack of contamination procedures for sterility and incomplete records for product batches.

Read our coverage here.

*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.