Amid looming tariff threats and a war cry by President Donald Trump to return manufacturing to the United States, the FDA continues to face persistent challenges overseeing foreign drug manufacturing, particularly in China and India.
While the agency has ramped up post-pandemic inspections and introduced new tools such as unannounced visits, its ability to consistently monitor global supply chains remains limited by staffing gaps and oversight inconsistencies.
According to a 2025 Government Accountability Office (GAO) report, the FDA is contending with 51 investigator vacancies — many in roles critical to foreign inspections. Attrition among drug inspectors remains high and the agency is still struggling to recruit personnel to its overseas posts.
As a result, the FDA has not yet returned to pre-pandemic levels of foreign site inspections, and congressional leaders have expressed concern about wide discrepancies in inspection outcomes.
A congressional analysis of FDA inspection records from 2014 to 2024 found stark variations among individual investigators. Some found compliance issues at nearly every site they visited, while others rarely cited violations — even at facilities in countries known for past quality control failures. Lawmakers have questioned whether the agency’s current inspection model is adequate to detect systemic problems across the global drug supply.
In response, the FDA has launched a pilot program to assess the effectiveness of unannounced inspections and has committed to improving oversight models. However, the GAO warned that until the agency defines and evaluates these new approaches — and addresses its workforce gaps — foreign manufacturing oversight will remain a high-risk area for the U.S. drug supply.
Still, the FDA in 2025 has hit several drugmakers with warning letters, import alerts, and Form 483s for manufacturing lapses ranging from data integrity violations to sterility assurance failures.
1. Chara Biologics
Chara Biologics, based in Pelham, New Hampshire, specializes in regenerative medicine products derived from perinatal tissues. Their offerings include CharaExo, CharaCore, and CharaOmni, which are marketed for various therapeutic applications. The company emphasizes minimal manipulation of tissues to preserve their natural properties.
On Jan. 17, 2025, the FDA issued a warning letter to Chara Biologics for marketing unapproved human umbilical cord-derived products and violating biologics regulations. The agency cited significant violations, including inadequate aseptic processing, lack of validated manufacturing processes, and false or misleading labeling with unsupported expiration dates. The FDA deemed the products adulterated and misbranded under the FD&C and PHS Acts.
2. BioStem Technologies
BioStem Technologies, headquartered in Pompano Beach, Florida, focuses on the development and commercialization of allografts for regenerative therapies. Utilizing their proprietary BioREtain method, they aim to preserve the natural properties of perinatal tissues in their products, such as OROPRO, PROVISCUS, NEOFYL, and RHEO. The company contends that it operates an FDA-registered and AATB-accredited facility, adhering to current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP).
On the same day as Chara Biologics, BioStem Technologies received a warning letter from the FDA for marketing unapproved biologics and failing to comply with cGMP standards. The FDA’s inspection highlighted deficiencies in the company’s quality control systems and laboratory testing procedures, raising concerns about product safety and efficacy. The agency classified the products as adulterated.
3. Jagsonpal Pharmaceuticals
Jagsonpal Pharmaceuticals, established in 1978 and based in New Delhi, India, focuses on the development and manufacture of pharmaceutical products in the gynecology and orthopedics segments. Their product portfolio includes formulations like Lycored, Maintane, Metadec, and Doxypal DR.
On Feb. 5, 2025, the FDA issued a warning letter to Jagsonpal Pharmaceuticals for obstructing FDA inspectors, refusing entry, and limiting access to essential documentation. The company also failed to ensure that its contract manufacturer complied with cGMP standards and had not validated its manufacturing processes or analytical methods. As a result, the FDA placed the company on Import Alert 66-40, restricting its ability to ship drug products to the U.S.
4. Tyche Industries
Tyche Industries, headquartered in Hyderabad, India, is engaged in the manufacture and export of active pharmaceutical ingredients (APIs), intermediates, chiral intermediates, and nutraceuticals. The company primarily exports its products to the U.S. and Europe.
On Feb. 6, 2025, the FDA issued a warning letter to Tyche Industries for cGMP violations, including falsification of manufacturing data, inadequate cleaning procedures, and failure to properly test incoming raw materials. These violations led the FDA to deem its products adulterated and resulted in Import Alert 66-40, barring them from U.S. importation.
5. Piramal Pharma (Turbhe Facility)
Piramal Pharma Limited, part of the Piramal Group, operates globally with a presence in over 100 countries. Their Turbhe facility in Navi Mumbai, India, is involved in the manufacture of APIs and formulations.
Between Feb. 11 and 17, 2025, the FDA conducted an inspection at Piramal’s Turbhe facility, resulting in a six-observation Form 483. The agency noted equipment leaks, a lack of written procedures for the QC unit, and incomplete deviation investigations. Inspectors also highlighted deficient recordkeeping and cleaning validation, raising concerns about the company’s overall control over its processes.
6. BPI Labs
BPI Labs LLC, located in Largo, Florida, is a contract manufacturer specializing in personal care and cosmetic products. The company offers services including formulation, manufacturing, filling, and packaging of various products like bath salts, scrubs, lotions, and hair care items.
On Feb. 21, 2025, the FDA issued a Form 483 to BPI Labs after finding that compounded drug labels lacked mandatory information required under Section 503B, including the statement “Office Use Only.” The omission affected multiple sterile injectable batches, including semaglutide and tirzepatide vials, and raised concerns about compliance with labeling regulations for office-administered compounded drugs.
7. Gland Pharma
Gland Pharma, established in 1978 and headquartered in Hyderabad, India, is a major global supplier of injectable drugs. The company specializes in complex injectables including vials, prefilled syringes, lyophilized products, and oncology medications. It serves both regulated and semi-regulated markets, with the U.S. being one of its largest export destinations. Gland has grown through a mix of CDMO partnerships and its own product development, and has several FDA-approved manufacturing facilities in India.
In February 2025, the FDA conducted a pre-approval inspection at Gland Pharma’s site in Visakhapatnam, Andhra Pradesh. The agency issued a Form 483 with three observations. While Gland described the findings as procedural and not related to data integrity, such issues can still delay or impact approvals for sterile APIs. The company stated it would address all issues and submit a corrective action plan within the FDA’s required timeframe.
8. Eagle Pharma Outsourcing
Eagle Pharma Outsourcing is a 503B outsourcing facility based in Hoover, Alabama. It compounds sterile and non-sterile medications primarily for office use, supplying products such as injectables for hormone therapy, pain management, and wellness treatments. The company serves clinics and hospitals across the U.S., operating under FDA regulations specific to outsourcing facilities created under the Drug Quality and Security Act.
On Feb. 27, 2025, the FDA issued a Form 483 after identifying repeated failures in aseptic processing during an inspection. Issues included turbulent airflow in vial filling, inadequate gowning procedures, incomplete smoke studies to assess airflow patterns, and insufficient cleaning between batches. Some of these were repeat citations from prior inspections, indicating ongoing noncompliance in sterile drug compounding.
9. Granules India
Granules India, headquartered in Hyderabad, is a vertically integrated pharmaceutical company known for producing APIs, pharmaceutical formulation intermediates, and finished dosage forms. It manufactures several widely used drugs, including acetaminophen, ibuprofen, and metformin, supplying both domestic and international markets, including the U.S. and Europe.
The Telangana-based facility came under scrutiny after an FDA inspection conducted in late 2024. On Feb. 26, 2025, the agency issued a warning letter citing microbial contamination risks, poor facility maintenance, and discarded cGMP records.
Inspectors found bird droppings in manufacturing zones, microbial contamination in air handling units, and residues from previously produced drugs. The FDA rejected the company’s initial remediation plan and warned that failure to correct the issues could jeopardize future product approvals and U.S. market access.
10. Jiangsu Hengrui Pharmaceuticals/Elevar Therapeutics
Jiangsu Hengrui Pharmaceuticals is one of China’s largest pharmaceutical companies, with a broad portfolio of cancer, cardiovascular, and pain management drugs. It operates multiple manufacturing and R&D facilities, including the Suzhou site involved in the FDA’s recent inspection. Elevar Therapeutics, a Utah-based company and U.S. partner to Hengrui, focuses on oncology drug development and has been spearheading the submission of the camrelizumab plus rivoceranib combination for liver cancer in the U.S.
In March 2025, the FDA issued a second Complete Response Letter (CRL) for the camrelizumab/rivoceranib NDA, citing new unresolved manufacturing deficiencies at Hengrui’s Suzhou facility. The site had previously received a 10-page Form 483 in 2024 outlining data integrity failures, contamination risks, and raw material handling lapses.
Despite resubmitting the application in late 2024 with positive Phase 3 survival data, the combination therapy remains unapproved in the U.S. due to the fixed-dose format, which prevents rivoceranib from being approved separately. The companies now plan to pursue regulatory approval in Europe.
