Staska Pharmaceuticals, Inc. — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

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. The FDA investigator also noted CGMP violations at your facility, that caused your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…

Regarding your firm’s failure 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: a. We acknowledge that your firm recognized FDA’s requirement to establish the reliability of the supplier's certificate of analysis (COA); clarified and provided documentation for the recovery of gram-negative bacteria and/or yeast at their facility; confirmed the supplier's COA supports growth of gram-negative bacteria and yeast by a 3rd party testing laboratory. However, the COA from your firm’s media supplier was not provided to show growth promotion testing was evaluated. In addition, a full copy of revision of SOP MC015 Growth Promotion Test of Microbiological Media was not provided. In addition, in your 10/18/2024 response, your firm committed to performing growth promotion testing. However, this was not provided in your 01/31/2025 update. Some of your corrective actions appear deficient…

Your firm 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 firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas: a. We acknowledge that you have removed personnel monitoring from SOP MC0l0, Environmental Monitoring, and drafted a new SOP MC028 Aseptic Filling Room Personnel Monitoring ; however, you did not provide complete copies of SOP MC028 and SOP MC0l0 . In addition, you stated a retrospective review of all personnel monitoring data for 2024 was…

Regarding your firm’s failure to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions: a. We acknowledge your firm is committed to ensuring your qualification program is representative of current manufacturing operations, a robust training program is in place, and will draft procedures…

Aseptic operators reaching into the ISO 5 laminar flow hood past their elbows during aseptic production. However, microbial contamination action limit for personnel monitoring of the elbows is (b)(4) . This practice may introduce contamination into the ISO 5 work area.

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).

Some of your facility’s drug products, such as (b)(4) and Glutathione Solution 2000mg/10ml (200mg/ml), did not include the following information on the container: information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088. In addition, some of your facility’s drug products, such as Ascorbic Acid Solution 25000mg/50ml (500mg/ml) and Lidocaine HCl 2% Buffered Solution 1000mg/50ml (20mg/ml), also did not include the following information on the…

Regarding your firm’s failure 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: a. We acknowledge that your firm initiated CAPA/ PD/010/24 (Annexure 7.A.1 ) to include the review and revision of media fill protocol; revision of all media fill batch manufacturing records (BMRs) to include…

Regarding your firm’s failure to thoroughly investigate other lots that may have been affected due to defects including glass particles, package defects, sealing defects and abnormal fill volume: a. We acknowledge that your firm-initiated deviation DR/PD/22/09/004 on 10/01/2022; however, you did not expand the investigation to other lots to confirm this was an isolated issue. In your 10/18/2024 response, you did not provide documentation for vial lot reconciliation, such as…

Your firm 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)). 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…

Regarding your firm's failure to establish written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess: a. We acknowledge that your firm has completed the first process validation (PV) study for Buffered Lidocaine HCI 2%, 20 mg/ml 50 ml vial and provided the protocol, also, that you initiated CAPA/PD/009/24 on 09/20/2024, provided Master Process Validation Protocol and Record of Observations. You also stated that your firm's "overall target completion timeline for this CAPA is (b)(4) ." These corrective actions cannot be fully evaluated until FDA receives the status updates for in-process activities and summary reports for the completed PVs. In addition, the interim status of your firm's current operations for all drug products is unclear.

Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

Your facility compounded drug products using a bulk drug substance from (b)(4) , which is not a registered establishment under section 510 of the FDCA.