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FDA Warning Letter Explorer
FDA warning letter · Drugs

Southern Tier Home Infusion, Inc. dba Pharmacy Innovations

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

Your firm failed to use a sporicidal agent as part of your disinfection program on the plexiglass shield inside your **(b)(4)** ISO 5 classified LAFW.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 200.10(b)
  • 21 CFR 201.115
  • 21 CFR 210.1(b)