近日，路透社報導了FDA檢查禮來公司新澤西州抗體生產工廠的消息，FDA批評該工廠"對計算機系統控制不力"。消息人士透露，缺陷包括刪除製造過程相關的數據，以及紙質審計跟追蹤的質量控制失敗，檢查結果確認為OAI，這是FDA缺陷觀察的最嚴重級別。
據路透社消息，禮來布蘭斯堡工廠不僅沒有通過FDA的檢查，在檢查前，現場工作人員已經警告公司官員有關問題，集中在人手不足和偽造記錄上。
報導如下：
Just days after Eli Lilly sentan COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chanceswere halted by a damaging trial stop for the therapy. Now, the FDA has knockedLilly for its manufacturing controls at a New Jersey site producing theantibody.
就在禮來將COVID-19抗體提前送到FDA審查的幾天後，因該療法的破壞性試驗，該公司放棄了眼前的機會。而現在，FDA對禮來在新澤西州的一個生產抗體的工廠的生產控制提出質疑。
The FDA cited Lilly's Branchburg, NewJersey, facility on two counts of inadequate "control of computersystems," Lilly confirmed in an email. Those two findings included deleteddata on the company's manufacturing processes and failed quality control overaudit paper trails, sources told Reuters.
禮來在一封電子郵件中證實，FDA批評了禮來位於新澤西州布蘭斯堡的工廠，指控其"對計算機系統控制不力"。消息人士透露，缺陷包括刪除製造過程相關的數據，以及紙質審計跟追蹤的質量控制失敗。
While Lilly assured that the flawsweren't tied to its production of COVID-19 antibody LY-CoV555, which isproduced on site, the findings could complicate the therapy's bid foran emergency use authorization.
雖然禮來保證這些缺陷與該工廠生產的COVID-19抗體LY-CoV555無關，但這些缺陷可能會使該療法申請緊急使用授權變得複雜。
After an inspection in November, FDAinvestigators flagged the quality control deficiencies in a notice sent toLilly, the drugmaker said. The investigators' findings qualified as officialaction indicated (OAI) in the notice, the highest enforcement priority levelfrom the FDA for its observations.
禮來表示，在11月的一次檢查之後，FDA檢查人員在發給禮來的通知中指出了質量控制的缺陷。在通知中將檢查結果確認為OAI，這是FDA缺陷觀察的最高級別。
In response, Lilly drafted a remediationplan and has been "working aggressively to resolve the issuesidentified," including hiring an external consultant and bringing onmore workers to offset an increased workload tied to production ofactive pharmaceutical ingredients (APIs).
作為缺陷回復，禮來起草了一份補救計劃，並一直在"積極努力解決已查明的問題"，包括聘請外部顧問，並僱傭更多員工以彌補與活性藥物成分 （API） 生產相關的工作量增加。
The drugmaker hasn't received anyfurther enforcement notices or warning letters from the FDA and said thefindings haven't hit its API supplies.
該製藥商目前未收到FDA的進一步執法通知或警告信，並表示，檢查結果未直接影響其API供應。
Lilly's Branchburg plant not onlyflopped its FDA inspection, but on-site workers had already warned company officialsabout the issues before the walk-through, according to Reuters sources.Those complaints reportedly centered on understaffing andfalsified records.
據路透社消息，禮來布蘭斯堡工廠不僅沒有通過FDA的檢查，而且在檢查前，現場工作人員已經警告公司官員有關問題。據報告，這主要集中在人手不足和偽造記錄上。
However, Lilly contended theFDA found no evidence of falsified records during its inspection. Thedeletions cited in the Reuters report were tied to "equipment set upactivities prior to use," Lilly said, and not actual manufacturing runs.
然而，禮來辯稱，FDA在檢查過程中沒有發現任何偽造記錄的證據。禮來說，路透社報導中引用的刪除內容與"設備使用前的設置活動"有關，而不是實際的生產過程。
"At no point was data deleted thatwas related to an actual production run and there has been no impact on productquality or safety," a Lilly spokeswoman said.
禮來發言人說："從未刪除任何與實際生產操作相關的數據，也沒有對產品質量或安全性產生影響。」
The FDA's hammer drop comes as a one-twopunch to Lilly's chances at an emergency nod for LY-CoV555 after the NationalInstitutes of Health (NIH) halted a late-stage trial for the antibody Tuesday.
周二，美國國家衛生研究院（NIH）停止了對該抗體的後期試驗，FDA的檢查是對禮來公司的LY-CoV555來說是一次沉重打擊。
The trial's independent data safetymonitoring board recommended the company pause enrollment, a Lilly spokesperson told CNBC in an email Tuesday,adding, 「Lilly is supportive of the decision by the independent DSMB to cautiouslyensure the safety of the patients participating in this study."
禮來發言人周二在一封電子郵件中表示：試驗的獨立數據安全監督委員會建議公司暫停註冊，並補充說，"禮來支持獨立數據安全監督委員會的決定，謹慎確保參與這項研究的患者的安全。
The news comes one day afterJohnson & Johnson paused a phase 3 study for itsCOVID-19 vaccine because a patient had an 「unexplained illness」—and about amonth after AstraZeneca suspended a trial for its COVID-19jab because a patient developed transverse myelitis, a type of spinal cordinflammation that can be triggered by infections.
這一消息出現前一天，強生公司暫停了COVID-19疫苗的三期試驗，因為患者出現"不明原因的疾病"；大約一個月前，阿斯利康暫停了COVID-19疫苗的試驗，因為患者出現了橫向骨髓炎，這是一種脊髓炎症，可由感染引發。