Findings
1Aseptic processing and sterility assurance
Regarding the repeat deficiencies identified in your smoke studies, your firm indicated that new smoke studies were performed on 07/30/2025 using protocols (b)(4) and (b)(4) . However, you did not provide copies of these protocols and the corresponding new smoke studies. Without this supporting documentation, your firm’s assertion that the new smoke studies demonstrate and reflect the following corrective actions cannot be verified: a. “Updated smoke studies will clearly…
2Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Additionally, the FDA investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Fluorescein 2% Ophthalmic Solution was subpotent (lots # 01242025@ (b)(4) , potency of 85.865% and 03272025@ (b)(4) , potency of 76.1475%). Under section 501(b) of the FDCA [21 U.S.C. §…
3Aseptic processing and sterility assurance
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
4Environmental monitoring
Regarding your production areas having surfaces that are difficult to clean or contain porous, particle generating surfaces, your firm provided several documents: the reconstruction floor plan for the remodeling of PS-112 cleanroom suite, the construction proposal and repairs punch list, and images of the ceiling tiles and walls of the newly remodeled area still under construction. However, you did not include adequate information or supporting documentation for review…
5Aseptic processing and sterility assurance
Regarding your firm releasing drug products where strength differs from, or quality or purity falls below, that which the products purport or are represented to possess, your firm’s Standard Operating Procedures (SOP) contain conflicting provisions regarding release of drug products intended to be sterile prior to receiving final sterility testing results raising significant concerns about product quality and patient safety. In your response, you provided SOP ID…
About this record
Extracted automatically from the document US FDA published on 2026-02-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
Other records for this company
