10月1日，FDA藥品評價和研究中心（CDER）向上海醫藥工業研究院（Shanghai Institute of Pharmaceutical Industry）分析測試中心發出警告信。
警告信中指出，FDA原計劃於2018年11月29日-12月4日對位於上海浦東區哥白尼路285號的上海醫藥工業研究院進行例行的檢查和藥品批准前現場檢查。上海醫藥工業研究院2018年12月4日就該項事先公布的檢查計劃向FDA中國辦公室以書面回復的形式拒絕了檢查。上海醫藥工業研究院分析測試中心是第三方藥品檢測機構，為美國ANDA申請提供API結構表徵、雜質鑑定等檢測服務。
根據FD&C Act法案501(j)部分規定，藥品在生產、加工、包裝、儲存的各個環節，如果企業的所有者、經營者或代理機構延誤、抵制、限制檢查或拒絕允許進入或檢查，該藥品可視為摻假藥。
具體規定見連結：https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf.
FDA指出，在被獲準進入檢查以及確認符合cGMP標準之前，FDA CDER可能會拒絕上海醫藥工業研究院相關的任何ANDA，並希望在警告信公布後的15日內收到回復。
Rablon – In March, the FDA cited Rablon for selling misbranded and unapproved new drugs, including medications aimed at the abortion market. On its website, Rablon was selling a combination pack of mifepristone and misoprostol tablets, marketed as 「Abortion Pill Pack」 and was described as a "medicinal treatment that is meant for the [sic] females having urge for discontinuing with their pregnancy.」
Rablon - 3月，FDA 警告 Rablon銷售貼有品牌和未經批准的新藥，包括針對墮胎市場的藥物。在其網站上，Rablon正在銷售米非司酮和米索前列醇片劑的組合包裝，作為「墮胎藥丸包」銷售，並被描述為「藥物治療，旨在幫]女性停止懷孕。」
Hospira Healthcare India – The FDA cited Hospira Healthcare India following a 2018 inspection of the company’s manufacturing facility in India. The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the facility. Violations include inadequate record keeping, discrepancies in drug batches, and a lack of quality control in determining if each batch manufactured met CGMP codes.
Hospira Healthcare India - 在2018年對該公司在印度的製造工廠進行檢查後，FDA 警告了Hospira Healthcare India。該警告信總結了該設施成品藥品的重大違反現行良好生產規範（cGMP）規定的情況。違規行為包括記錄保存不足，藥品批次不一致以及缺乏質量控制以確定每批產品是否符合cGMP規範。
Laboratorios Quantium LLC – The Florida-based Laboratorios Quantium was also cited for CGMP violations for finished pharmaceutical products. Particularly, the FDA cited concerns over product labeling the showed the product was an unapproved new drug.
Laboratorios Quantium LLC - 位於佛羅裡達州的Laboratorios Quantium也因成品藥品的cGMP違規而被警告。特別是，FDA引用了對產品標籤的擔憂，表明該產品是未經批准的新藥。
Phi Sciences – Arizona-based Phi Sciences was also cited for violations of product labels regarding supplements it sold on its website.
Phi Sciences - 位於亞利桑那州的Phi Sciences也被列為違反其網站上銷售的補品的產品標籤。
Nutra Pharma – Florida-based Nutra Pharma was cited for selling products on their website that were inappropriately labeled. Following a review, the FDA found that the products sold were classified as unapproved new drugs.
Nutra Pharma - 總部位於佛羅裡達州的Nutra Pharma因在其網站上銷售的產品被貼上了不恰當的標籤而被警告。經過審查，FDA發現所售產品被歸類為未經批准的新藥。
Jubilant Generics – India-based Jubilant was cited for CGMP violations. There were batch discrepancies, as well as concerns over quality control of batches.
Jubilant Generics - 總部位於印度的Jubilant 因CGMP違規被警告。存在批次差異，以及對批次質量控制的擔憂。
Anicare Pharmaceuticals – Also based in India, Anicare was cited for CGMP violations. Concerns included a lack of written testing to assess stability of products, and failures from the quality control team to approve and review written procedures.
Anicare Pharmaceuticals - Anicare也位於印度，因CGMP違規而被引用。問題包括缺乏用於評估產品穩定性的書面測試，以及質量控制團隊未能批准和審查書面程序。
King Bio – N.C.-based homeopathic drugmaker King Bio Inc. was cited for selling misbranded drugs, as well as inadequate CGMP procedures. That warning letter followed Kin Bio’s recall of 32 different homeopathic treatments last year. The therapies were recalled due to microbial contamination.
King Bio - 基於NC的順勢療法製藥商King Bio Inc. 因出售貼錯標籤的藥物以及cGMP程序不足而被警告。去年，Kin Bio 召回了32種不同的順勢治療方法。由於微生物汙染，召回治療產品。
Theodonrx.net – The FDA issued a warning letter to Thedonrx.net for the sale of opioids that are misbranded and unapproved new drugs.
Theodonrx.net - 美國食品藥品管理局向Thedonrx.net 發出警告信，其銷售貼品和未經批准的阿片類新藥。
Tec Laboratories – Oregon-based Tec Laboratories was cited for selling a product that 「as formulated and labeled,」 was an unapproved new drug. The FDA also cited Tec for CGMP violations.
Tec實驗室 - 總部位於俄勒岡州的Tec Laboratories因出售「配方和標籤」的產品而被警告，該產品是未經批准的新藥。FDA還引用了Tec的cGMP違規行為。
Vanda Pharmaceuticals – Vanda was cited for its websites failure to include any risk information about two drugs, Fanapt and Hetlioz. Fanapt carries a Boxed Warning. The web pages only included the benefits of the medications.
Vanda Pharmaceuticals - Vanda因其網站未能包含有關兩種藥物Fanapt和Hetlioz的任何風險信息而被警告。Fanapt攜帶盒裝警告。網頁僅包括藥物的好處。
MannKind Corporation – The FDA cited MannKind over a Facebook page promoting its insulin powder, Afrezza. The page made false or misleading claims about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug. Afrezza carried a Boxed Warning.
MannKind公司 - 美國食品和藥物管理局在一個推廣其胰島素粉末的Facebook頁面上警告 MannKind，Afrezza。該頁面通過暗示沒有與使用該藥物相關的安全問題，對與Afrezza相關的風險做出了虛假或誤導性聲明。Afrezza帶著盒裝警告。
RIJ Pharmaceuticals – The FDA cited RIG over its CGMP violations, including failures to have adequate written procedures and laboratory controls. The company also failed to test its drugs for impurities.
RIJ Pharmaceuticals - FDA 警告 RIG對其CGMP違規行為進行了警告，包括沒有足夠的書面程序和實驗室控制。該公司也沒有測試其藥物中的雜質。
AMMD Labs – Florida-based AMMD Labs was cited by the FDA for significant violations of CGMP regulations for finished pharmaceuticals. The FDA said the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP.
AMMD實驗室 - 位於佛羅裡達州的AMMD實驗室被FDA 警告為嚴重違反CGMP成品藥品法規的行為。FDA表示，公司製造，加工，包裝或保管的方法，設施或控制措施不符合CGMP。
Centurion Laboratories – India-based Centurion Laboratories was cited for CGMP failures. The facility was faulted for incomplete data regarding testing compliance. The FDA said during its 2018 inspection investigator found torn documents of stability study data, analytical testing sheets, analysis calculations and release forms placed into clear trash bags.
Centurion Laboratories - 總部位於印度的Centurion Laboratories 因CGMP失敗而被警告。該設施因測試合規性的不完整數據而出現故障。美國食品和藥物管理局在其2018年檢查期間表示，研究人員發現穩定性研究數據，分析測試表，分析計算和釋放形式的文件已被撕裂，放入透明垃圾袋。
Rocky Mountain Pharmacy – Compounding Rocky Mountain Pharmacy, located in Montana, said the facility failed to live up to compounding safety data established by the FDA. Additionally, the FDA said its investigator noted that drug products were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.
落基山藥房 - 位於蒙大拿州的複合落基山藥房表示，該設施未能實現複合FDA制定的安全數據。此外，美國食品和藥物管理局表示，其研究人員指出，藥品是在不衛生的條件下製備，包裝或保存的，因此它們可能已被汙染或汙染健康。
Kingston Pharma – New York-based Kingston was cited for CGMP violations. The FDA also noted that over-the-counter children’s medicine was misbranded, which made them ineligible to be sold.
金士頓製藥 -總部位於紐約的金士頓警告了CGMP違規行為。美國食品和藥物管理局還指出，非處方兒童的藥物是貼錯標籤的，這使他們沒有資格被出售。
Pharmasol Corporation – The FDA cited two separate Pharmasol Corporation facilities in Massachusetts for CGMP violations. The company failed to investigate batch discrepancies, leaks in the machines and failed to establish an adequate quality control unit.
Pharmasol公司 - 美國食品和藥物管理局在麻薩諸塞州警告了兩個Pharmasol公司的CGMP違規設施。該公司未能調查批次差異，機器洩漏以及未能建立適當的質量控制單元。
Ingenue Care – Norwalk, Calif.-based Ingenue was cited for CGMP violations at its manufacturing facility, including the misbranding of drugs produced there.
Ingenue Care - 總部位於加利福尼亞州諾沃克的Ingenue 公司因其製造工廠的CGMP違規行為被警告，其中包括在那裡生產的藥品的錯誤標識。
Vida International – Taiwan-based Vida was cited for CGMP failures at its Taiwan manufacturing facility. The company failed to perform satisfactory batch tests, including the identity and strength of each active ingredient.
Vida International - 總部位於臺灣的Vida 因其臺灣製造工廠的CGMP故障被警告。該公司未能進行令人滿意的批次測試，包括每種活性成分的特性和強度。
McDaniel Life-Line LLC – The FDA cited McDaniel over the sale of products that are unapproved drug formulations. On its website it sells a product called Indian Herb, which the FDA said is classified as unapproved. Also, the FDA said the product was made in a facility that had unsanitary conditions.
McDaniel Life-Line LLC - FDA 警告了 McDaniel關於銷售未經批准的藥物配方的產品。在其網站上，它出售一種名為Indian Herb的產品，FDA稱其被歸類為未經批准。此外，FDA表示該產品是在不衛生條件下生產的。
Somalabs, Inc. – Somalabs was cited for violating CGMP standards that caused the dietary supplements manufactured on site to be adulterated. The regulatory agency said part of that was due to the company failing to confirm the components in the product met approved standards.
Somalabs，Inc。- Somalabs因違反CGMP標準而被警告，該標準導致現場製造的膳食補充劑摻假。監管機構表示，部分原因是該公司未能確認產品中的組件符合批准的標準。
KratomNC – KratomNC was cited for selling unapproved drug products that contain kratom, an herbal extract that has not been approved for use in the U.S., with claims that they could treator cure opioid addiction and withdrawal symptoms.
KratomNC - KratomNC因出售未經批准的含有kratom的藥品而被警告，kratom是一種尚未批准在美國使用的草藥提取物，聲稱可以治療或治療阿片類藥物成癮和戒斷症狀。
Aurobindo Pharma Limited – Aurobino’s Telangana India facility was cited for significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). Some of the violations included a failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications.
Aurobindo製藥有限公司 - Aurobino的Telangana印度工廠因與活性藥物成分（API）目前的良好生產規範存在重大偏差而被警告。一些違規行為包括未能確保與API接觸的設備表面不會改變API的質量，超出官方或其他既定規範。
Izeen Pharma – Izeen was cited for CGMP violations, including the introduction into interstate commerce of thyroid tablets levothyroxine and liothyronine. The drugs were misbranded and other violations were noted.
Izeen Pharma - Izeen因CGMP違規被警告，包括引入甲狀腺片左旋甲狀腺素和碘塞羅寧的州際貿易。這些藥物是貼錯標籤的，並注意到其他違規行為。
Akorn Pharma – The company’s New Jersey site was cited for CGMP violations, including the failure to investigate unexplained discrepancies between batches and failure to exercise controls over computer systems.
Akorn Pharma - 該公司的新澤西州網站因CGMP違規被警告，包括未能調查批次之間無法解釋的差異以及未能對計算機系統實施控制。
Strides Pharma Science Limited – The India-based company was cited for CGMP violations that included the failure to establish an adequate quality control unit and the failure to investigate any unexplained discrepancies in batches.
Strides Pharma Science Limited - 這家總部位於印度的公司因CGMP違規而被警告，其中包括未能建立適當的質量控制單位以及未能分批調查任何無法解釋的差異。