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FDA Warning Letter Explorer
FDA warning letter · Drugs

Walfer Corporation dba The Medicine Shoppe Pharmacy

Issued · Posted by FDA

FDA published a close-out letter on Sep 26, 2022. The passages below are from the original warning letter.

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 maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).

Passage 2

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)).

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)
  • 21 CFR 211.56(a)
  • 21 CFR 211.67(a)