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# Eye Product Manufacturer Hit with Warning Letter
- URL: https://www.fdaweb.com/eye-product-manufacturer-hit-with-warning-letter/
- Published: 2024-09-06T12:00:00.000Z
- Updated: 2026-09-14T14:40:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157726

FDA has issued Regenerative Processing Plant a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/regenerative-processing-plant-llc-672154-08162024?ref=fdaweb.com) based on a 6/2023 inspection of the firm’s Palm Harbor, FL, manufacturing facility that found significant GMP violations involving its ophthalmic drug products, Regener-Eyes Professional (PRO) Ophthalmic Solution and Regener-Eyes LITE Ophthalmic Solution. Based on claims being made about the products, FDA’s letter also says the eye products are considered unapproved new drugs.

For example, the agency says the products are formulated with the active ingredient “tonicity solution sodium chloride” which “is not an active ingredient that is permitted for ophthalmic demulcents” under the OTC monograph.” The products also fail to include certain required labeling statements, such as warnings required for ophthalmic demulcents under the monograph, it says.

Regarding GMP violations, FDA cited the firm for:

1. Failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products.
2. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area necessary to prevent contamination or mixups.
3. Failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.
4. Failure to conduct at least one test to verify the identity of each component of a drug product.
5. Failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.
6. Failure to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7. Failure to maintain production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch.
8. Failure to retain an appropriately identified reserve sample that is representative of each lot or batch of drug product.

Additionally, the letter acknowledges corrective actions that the firm identified in response to a Form FDA-483 that was issued at the end of the inspection. These include the firm’s decision to voluntarily suspend manufacturing operations until after it completes the planned corrective actions, and its commitment to retain a GMP consultant to assist it in meeting GMP requirements.