FDA import alert shuts out two Chinese GLP 1 ingredient plants

Two Chinese makers of GLP 1 ingredients for American compounders are now shut out of the US market. Each FDA import alert listing names a whole factory: Chengdu Shengnuo Biopharm was added to the agency's red list on September 19, 2026, and Nanjing Chengong Pharmaceutical followed on October 1. Inspection reports described by Bloomberg point to mould, insects and unchecked raw material at the two plants.

Two plants on the red list

Under the FDA import alert system, both firms now sit on Import Alert 66-40, the list FDA uses for foreign drug makers it says have not met good manufacturing practice. Shipments from a listed firm can be held at the border without a physical examination. The FDA entry for Chengdu Shengnuo Biopharm gives an address on Xueshan Avenue in Dayi county, Chengdu, in Sichuan province. The entry for Nanjing Chengong Pharmaceutical gives an address on Xingang Avenue in Nanjing's economic and technological development zone in Jiangsu. In both cases the listing covers all drugs and drug products from the site rather than one ingredient, so any peptide or other active ingredient made there is caught by the same detention order.

The scope matters for buyers. Compounding pharmacies that had sourced semaglutide or tirzepatide ingredient from either plant, at a time when other Chinese makers line up semaglutide copies for their home market, now need another qualified supplier, since the detention order follows the factory and not a single product code. A firm leaves the red list only after FDA accepts evidence that the problems have been fixed, and the agency publishes no timetable for that review. Neither firm has said publicly when it expects to ask for removal, and a warning letter, if one comes, would be a separate step. The table below sets out what the FDA listings themselves show, which is narrower than the findings later reported in the press.

What inspectors reported at Chengdu Shengnuo

The detail of the inspections came from Bloomberg, as relayed by other outlets including NDTV. At Chengdu Shengnuo, inspectors reported black mould on equipment, floors they called grossly contaminated and significant insect activity in ceiling areas. The account also described staff trying to hide documents in lockers and pouring product samples into sinks after the inspection team arrived. The parent company, Chengdu Shengnuo Biotec, which trades in Shanghai, disclosed that FDA inspected in August 2026 and issued a Form 483 with eight observations. Those covered contamination control, critical quality attributes, the reliability of test results and how the quality system is governed. The parent said it had filed an initial response to the agency.

In plain terms, material could be released under the Nanjing firm's name with no real check on where it came from or how it was made.

The financial exposure is large for a mid sized ingredient maker. VCBeat, a Chinese health business outlet, reported that the company said it would halt all sales and shipments of peptide ingredient to the United States until the alert is lifted. The same report put US revenue at RMB 167 million in the first half of 2026, or 32.83% of total revenue, and said the shares fell 18.61% on the day the listing was announced. It also reported that FDA had moved drug master files for tirzepatide and terlipressin ingredient to active status in May. Readers should treat those figures as the company's own disclosure as reported, since the filing itself was not available to us.

Nanjing Chengong and unchecked supply

The concern at Nanjing Chengong was different. According to the inspection account reported by Bloomberg, workers bought active ingredients made by other factories and then applied their own approval seals without reviewing the outside suppliers' safety and quality data. In plain terms, material could be released under the Nanjing firm's name with no real check on where it came from or how it was made. For a buyer downstream, that breaks the chain of evidence that a certificate of analysis is meant to provide. A compounder reading such a certificate would have no way of knowing that the plant named on it was not the plant that made the batch.

This is why the FDA import alert entry covers every product from the site. FDA did not say which ingredients from Nanjing Chengong had reached the United States, how much volume was involved or which pharmacies bought it, and the firm has not commented in sources we could reach. The reported findings also do not show that any given batch was contaminated or that patients were harmed, and the agency has not made that claim. What the red list entry does establish is that FDA no longer accepts the firm's paperwork at the border. Any future shipment would have to prove compliance first, and the burden of that proof now rests with the importer.

The Green List rule behind the crackdown

The two listings sit alongside a wider rule. Import Alert 66-80, first issued in 2025, lets FDA detain any foreign GLP 1 ingredient unless the maker and product appear on a Green List of sites the agency judges compliant. In a major revision published on October 9, 2026, the Green List alert says FDA used inspections and records requests to check 48 GLP 1 ingredient sites and found 21% noncompliant. Some sent records that showed problems, while others did not answer in time. FDA also described a pattern of firms that register, offer ingredient for import, refuse records requests and then deregister within a short period.

The agency explains why it focuses on compounding. Pharmacies that compound under section 503A are exempt from manufacturing practice rules, including the duty to confirm that an ingredient meets impurity and potency specifications, so a bad ingredient may pass straight into a finished drug. A firm that wants onto the Green List must petition FDA's import division and send supporting data such as certificates of analysis for its last ten lots. The October revision also added product codes for orforglipron, Lilly's pill that acts on the same receptor. For context on earlier US moves aimed at some Chinese suppliers, see our report on the reworked BIOSECURE Act, which works through federal funding rather than the border.

Conclusion

The FDA import alert entries for Chengdu Shengnuo Biopharm and Nanjing Chengong close two Chinese sources of GLP 1 ingredient to US buyers, on top of a Green List system that already holds back unlisted makers. The reported findings range from mould and insects to resold ingredient released without checks. Open questions remain on how much US compounded supply came from these plants and when, if ever, either firm will apply to come off the list.