New England Life Care, Inc. dba Advanced Compounding Solutions
FDA issued a warning letter to New England Life Care, Inc. dba Advanced Compounding Solutions, a 503B outsourcing facility in Woburn, MA, following a March–April 2022 inspection that revealed serious CGMP violations and insanitary conditions in sterile drug production. The facility's compounded drug products — including Diltiazem HCl, Norepinephrine Bitartrate, Vancomycin HCl, and Phenylephrine HCl preparations — were found to be adulterated due to insanitary conditions (pest intrusion, blocked air returns, improper aseptic technique) and CGMP failures (inadequate investigations, complaint handling, sterilization validation, and cleaning procedures). Products also failed to meet 503B labeling conditions (missing dosage form on labels), rendering them ineligible for exemptions from FDA approval and adequate-directions-for-use requirements. FDA warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (3)
You do not have any FDA-approved applications on file for drug products that you compound.
some of your facility's drug products, including Diltiazem HCl 125mg in 100mL bag, Norepinephrine Bitartrate 8mg Dextrose 5% 250mL bag, Vancomycin HCl 750mg in 0.9% Sodium Chloride 250mL bag, and Phenylephrine HCl 20mg in 250mL bag, did not include the dosage form on the product label.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) 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.
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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