1Other quality system
Receipt of drugs from establishments not duly registered with FDA and failure to provide listing information to FDA Section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 set forth the requirements for establishment registration and drug listing. Under section 502(o), a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section…
2Other quality system
Failure to Ensure Adequate Pre-Release Testing of APIs Your firm lacked adequate QU oversight for the relabeling and repackaging of your API. Specifically, your firm failed to perform adequate testing and approve the results for your APIs prior to their release and distribution. For example, your firm released APIs for distribution prior to your QU completing its review. According to your records, your firm received and distributed a (b)(4) API, (b)(4) , lot (b)(4) on (b)(4)…
3Material and supplier control
Distribution of drugs lacking adequate directions for use You received retatrutide from your supplier, (b)(4) , FEI (b)(4) . 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. Additional APIs that you distribute or distributed to…
4Material and supplier control
Failure to Ensure that Your System for Evaluating Suppliers was Adequate FDA’s inspection revealed that your firm received API from (b)(4) , FEI (b)(4) . Darmerica also served as the firm’s U.S. agent starting in (b)(4) . Darmerica remained listed as the U.S. agent for (b)(4) until (b)(4) de-registered its establishment in FDA’s registration system on (b)(4) . The first documented shipment from (b)(4) to Darmerica was in (b)(4) , and the last shipment to Darmerica was in…
5Complaint and recall handling
Failure to Adequately Investigate Quality-Related Complaints and Recalls Our inspection also revealed that your firm did not adequately investigate customer complaints. Specifically, your QU failed to extend product quality complaint investigations to other lots of APIs potentially associated with the root cause, failure, or deviation. For example, you were made aware by (b)(4) on May 9, 2023, and (b)(4) on July 10, 2023, that (b)(4) lot (b)(4) manufactured by (b)(4) , FEI…
6Material and supplier control
Receipt of drugs whose labeling is false or misleading Under section 502(a) of the FD&C Act, a drug is misbranded if its labeling is false or misleading in any particular. Your firm received multiple shipments of API that you knew to be mislabeled. Since March 2022, GLP-1 APIs were shipped to your firm as “custom peptide,” omitting the drug name. Because of this material omission, the labeling of the drug is false or misleading, causing the drug to be misbranded under section 502(a). We note that you acknowledged that this occurred, indicating it was to prevent theft of high demand products and to address the country’s export requirements for specific peptides.
