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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Philadelphia 7, Inc d/b/a Passional Boutique

Issued · Posted by FDA

FDA published a close-out letter on Apr 6, 2026. 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

Our records indicate that the binders in the UNTAG line were manufactured, prepared, propagated, compounded, or processed in an establishment that was not duly registered and were not included in a list required by section 510 of the Act. Therefore, the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)).