US Specialty Formulations, LLC
FDA issued a warning letter to US Specialty Formulations, LLC, a 503B outsourcing facility in Allentown, PA, following a March–April 2022 inspection that revealed serious sterility assurance failures, CGMP violations, and labeling deficiencies. The facility's compounded sterile drug products were found to be adulterated due to insanitary conditions (e.g., use of non-sterile wipes in ISO 5 areas, inadequate aseptic technique, insufficient environmental monitoring) and multiple CGMP regulatory violations. Because the products failed to meet 503B conditions, they are also deemed unapproved new drugs and misbranded, and FDA warned that failure to remediate could result in seizure or injunction.
Flagged claims (5)
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
You do not have any FDA-approved applications on file for drug products that you compound.
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
your facility's drug products, for example Sarracenia Purpurea 0.17 g/mL, did not include the following information on the label: a list of active and inactive ingredients identified by established name and the quantity or proportion of each ingredient as required by section 503B(a)(10)(A)(iii)(X) of the FDCA.
Your facility's drug products, for example B-Complex plus Chromic Chloride 30 mL, did not include the following information on the label: the dosage form as required by section 503B(a)(10)(A)(iii) 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.
We acknowledge that on May 24, 2022, your firm initiated voluntary recalls of certain drug products intended or expected to be sterile, that were within expiry, due to a lack of sterility assurance.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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