Apollo Care, LLC — FDA Warning Letter Findings

You failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

You failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Regarding your smoke studies, we acknowledge you have initiated a revision of SOP CQI025 Air Flow Pattern Visualization and intended to conduct “formal static and dynamic smoke studies,” as stated in your June 10, 2025, response. Your September 8, 2025, response provided the protocol and report in Attachment 2 for the May 30, 2025, static smoke studies of the (b)(4) hoods, as part of CAPA C-25-013. However, the protocol and report did not specify what production equipment…

Regarding your firm’s use of the Hallway/Anteroom (b)(4) as both ISO (b)(4) and ISO (b)(4) space depending on whether you are conducting non-sterile or sterile activities, your response is inadequate because you provided contradictory and incomplete information on how the ISO (b)(4) Lab will be accessed. You continue using the Hallway/Anteroom (b)(4) as an entry to reach both non-sterile and sterile activities. In your June 10, 2025, follow-up response, you reiterated that…

Regarding white fiber-like particles and debris observed on the floor of the ISO (b)(4) Lab and the ISO (b)(4) Hallway/Anteroom (b)(4) following area cleaning, we acknowledge you rejected and destroyed the three affected lots. However, you have not provided any preventive actions regarding particles observed in the anteroom and in the cleanroom space where ISO (b)(4) LAFH used for production are located. In your June 10, 2025 response, the specification sheet from (b)(4) . (refer to pages 95-96 of the Response Attachment 3) appeared to be a specification sheet for (b)(4) Mop, which is a different product line, with part numbers such as (b)(4) , none of which appeared to match the mops being used at your firm.

Your firm’s aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing…

You used sanitizing and sporicidal agents without providing adequate segregation in preventing contamination of in-process bulk drug solution. Specifically, your operator repeatedly sprayed a microfiber mop head with cleaning agents near the beaker containing non-sterile bulk drug solution that was loosely covered with aluminum foil in the ISO (b)(4) classified Hallway/Anteroom (b)(4) during area cleaning.

Your firm had foreign matter in the production area. Specifically, white fiber-like particles and debris were observed on the floor of the ISO (b)(4) Lab, where ISO (b)(4) laminar air flow hoods (LAFHs) are located, and the ISO (b)(4) Hallway/Anteroom (b)(4) following area cleaning that included equipment, ceilings, walls, and floors.

You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO (b)(4) aseptic processing area. Instead, your firm approved and distributed drug products that were produced with 1 CFU recoveries found on ISO (b)(4) operator gowning gloves or sleeves.

Regarding the textured panels in your cleanroom suite, the manufacturer’s Technical Data sheet indicates the panels with textured or smooth surface have fire, mold and mildew resistance. However, there is no statement in the Technical Data sheet supporting the panel’s suitability for cleanroom applications, especially for pharmaceutical manufacturing facilities producing products intended to be sterile. Your response is inadequate because you have not evaluated the risk…

Regarding documentation of incomplete (b)(4) cycles, your SOP PRC002 Facility Cleaning Procedure only mandates documentation of “all executed facility cleanings.” However, the SOP fails to address the documentation requirements for incomplete (b)(4) cycles within individual rooms or incomplete “full clean” of the cleanroom suite (all (b)(4) rooms). CGMP regulations require comprehensive documentation of all CGMP activities, including those that are incomplete or terminated early. The SOP should be revised to include: Documentation requirements for all (b)(4) cycle attempts, whether completed or incomplete; and Explanation for partial or terminated cycles.

Regarding your firm’s cleaning of the ISO (b)(4) Hallway/Anteroom (b)(4) while non-sterile in-process bulk drug solution was stored there, your firm lacked assurance that the non-sterile in-process bulk drug solutions exposed to cleaning agents during this cleaning process do not alter the quality and purity of sterile compounded finished drug product produced from the exposed bulk drug solution. We acknowledge you will no longer store the bulk drug solution in the area…

Your firm had production areas or equipment that are difficult to clean or contain porous, particle-generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings). Specifically, wall panels overlaid on top of your ISO (b)(4) Hallway/Anteroom (b)(4) walls are not smooth. The textured surface is difficult to clean and may harbor contamination and generate particles when other materials come into contact with it. The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…