Findings
1Other quality system
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA (FD&C Act Section 582(c)(4)(A) & (B)). Under section 582(c)(4)(A) & (B) of the FD&C Act, wholesale drug distributors must have systems in place to enable the wholesale distributor to comply with the verification requirements of the DSCSA. Your firm was not able to demonstrate systems that would enable Safe Chain to comply with a number of verification requirements…
2Deviation, CAPA, and investigation
Your firm failed to maintain records of suspect product investigations (FD&C Act Section 582(c)(4)(A)(iii)). The DSCSA requires that wholesale distributors maintain records of investigations of suspect product for not less than 6 years. (FD&C Act section 582(c)(4)(A)(iii)). Your firm was both unable to provide any written documentation of what products were held in or released from quarantine, and unable to provide records explaining how suspect product was quarantined. In…
3Other quality system
Your firm conducted transactions with trading partners that were not authorized (FD&C Act Section 582(c)(3)). The DSCSA requires that trading partners of wholesale distributors meet the applicable requirements for being authorized trading partners. (FD&C Act Section 582(c)(3)). To be authorized, a wholesale drug distributor must have a valid license under State law or section 583 of the FD&C Act, in accordance with section 582(a)(6) of the FD&C Act, and comply with the…
4Other quality system
Your firm failed to respond to a notification of illegitimate product (FD&C Act Section 582(c)(4)(B)(iii)). Upon receiving a notification of illegitimate product, a wholesale distributor must identify all illegitimate product subject to such notification in its possession or control, including any product that is subsequently received. (FD&C Act section 582(c)(4)(B)(iii)). You are also required to quarantine such product within your possession or control from product…
About this record
Extracted automatically from the document US FDA published on 2023-06-27. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
