Darmerica, LLC

your firm received and distributed a (b)(4) API, (b)(4), lot (b)(4) on (b)(4). Though a sample was sent to your third-party testing laboratory for analysis, the (b)(4) distribution of the (b)(4) API occurred prior to your firm's own QU release of the (b)(4) API on (b)(4) and before the certificate of analysis (COA) was reviewed and authorized by your third-party lab

in your listing for the drug "Hexarelin Acetate" (NDC 71052-621), you list the active ingredient as peptide B27PD in the SPL. Similarly, in the listing for the drug API "Elamipretide (SS-31) Acetate" (NDC 71052-907), you list the active ingredient as peptide B27PD in the SPL.

Additional APIs that you distribute or distributed to compounders seeking to operate under section 503A of the FD&C Act that are ineligible for use in human drug compounding under sections 503A include: dapoxetine hydrochloride, 2-methoxyestradiol (2ME2), tesofensine, FGL acetate aka [GLP-1]-FGL peptide acetate, thymogen, buserelin acetate, elamipretide (SS-31) acetate, larazotide acetate, and cagrilintide acetate.

Retatrutide is a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA. You distributed this API to pharmacies seeking to compound human drugs under section 503A of the FD&C Act even though retatrutide is not eligible for use in compounding under section 503A.

GLP-1 APIs were shipped to your firm as "custom peptide," omitting the drug name.

The labeling of these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence.

Darmerica has ceased importing/distributing Retatrutide and delisted the NDC registration from FDA's CDER website. As discussed during the April 02, 2025, meeting with FDA, Darmerica stopped the importation and distribution of Cagrilintide and is in the process of delisting the NDC registration from the FDA's CDER website.

A detailed list containing API name, manufacturer name, manufacturer lot number, date of entry, import entry number, port of entry, order number, quantity, grade, usage, date of receipt, and information regarding the first date distributed, such as customer name and address, for all drugs received by your firm within three years from the date of this letter.

Whether you have notified your customers that they received adulterated drugs from your firm. If you have not notified any customer who received adulterated drugs from Darmerica, notify them, and provide a copy of that notification in your response. The notification should include lot identification, recommended actions, and customer acknowledgement.

Supplier qualification procedures implemented for new API manufacturers and supply chain verification measures taken by your firm, including the selection, qualification, and disqualification provisions.

A comprehensive assessment of your overall complaint system, including a comprehensive list of all complaints where you returned drugs to the manufacturer, as well as information on whether you contacted your customers to investigate each complaint and the date of that contact, if applicable.

Based upon the nature of the deviations identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.

A full reconciliation of any drugs from (b)(4), as well as for all firms or drugs currently on FDA import alerts, to determine if you have any remaining drugs from those firms in your possession.