FDA WARNING_LETTER - Jilin Shulan Synthetic Pharmaceutical Co. Ltd. - November 10, 2017

On May 14, 2018, the FDA issued a Warning Letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. following an inspection from November 7-10, 2017. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to document and investigate deviations and OOS results:** An undocumented manufacturing deviation was found, and dual sets of laboratory records for multiple batches showed uninvestigated Out-of-Specification (OOS) results, with passing results lacking supporting evidence. The firm's response regarding OOS was inadequate. 2. **Insufficient controls over computerized systems:** Audit trails were not enabled on instruments, electronic data backups were unsecured, and operators had full system permissions, including the ability to modify and delete files. 3. **Failure to record activities contemporaneously:** Examples included pre-signed, blank, or partially completed batch records, and data changes in pencil without justification.

The FDA noted that the firm's quality unit lacked sufficient authority and resources. The letter strongly recommended retaining a qualified consultant for remediation. Required corrective actions include a comprehensive investigation into data inaccuracies, a risk assessment of failures on drug quality, and a detailed management strategy with corrective and preventive actions, root cause analysis, and interim/long-term measures.

The firm was placed on Import Alert 66-40