Staska Pharmaceuticals, Inc.
FDA issued a warning letter to Staska Pharmaceuticals, Inc. (Bennet, NE), a 503B outsourcing facility, following a September 2024 inspection that revealed serious CGMP deficiencies in sterile drug manufacturing, including insanitary aseptic conditions, inadequate media fills, and failed smoke studies. The facility also failed to meet 503B conditions by using bulk drug substances from an unregistered supplier and omitting required labeling elements (adverse event reporting info, directions for use) on products such as Glutathione Solution and Ascorbic Acid Solution. As a result, the compounded drug products are deemed adulterated, misbranded, and unapproved new drugs under the FDCA. FDA required a written response within 15 working days and strongly recommended a comprehensive third-party assessment of aseptic processing operations.
Flagged claims (5)
You do not have any FDA-approved applications on file for drug products that you compound. Under sections 505(a) and 301(d) of the FDCA a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug.
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 container: directions for use, including, as appropriate, dosage and administration.
drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
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.
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.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.
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