FDA Slaps Warning Letters on 4 Global Giants Over Dirty Manufacturing Practices and Poor Quality Control
Investigations reveal critical gaps in sterile production and API manufacturing across India China and the United States
The United States Food and Drug Administration recently initiated a series of interventions targeting the global pharmaceutical supply chain. The agency issued warning letters to four distinct companies operating in China India and the United States. These communications highlight recurring problems with Good Manufacturing Practices or GMPs. The violations involve the production of Active Pharmaceutical Ingredients or APIs and finished drug products. From a clinical standpoint these failures represent a potential risk to patient safety. The agency identified insufficient oversight by quality units inadequate aseptic practices and a failure to learn from previous manufacturing errors across the different facilities.
Eugia Pharma Specialties Limited located in Hyderabad India serves as the first example of these systemic failures. The company is a subsidiary of Aurobindo Pharma and specializes in generic pharmaceutical formulations. Its focus includes sterile injectables and oncology treatments which require the highest level of environmental control. The FDA letter detailed that Eugia's aseptic processing lines were not well designed. Specifically the facility lacked adequate Restricted Access Barrier Systems or RABS. These systems are necessary to ensure proper ergonomics and physical separation from the surrounding environment. FDA stated that RABS are essential for minimizing or eliminating operator intervention in critical cleanroom environments.
According to the report operators were allowed to enter the lifting area of the aseptic line to perform manual interventions. This occurred without maintaining appropriate ISO 5 conditions. ISO 5 represents a standard of cleanliness defined by the International Organization for Standardization. In the context of pharmaceutical manufacturing this environment is critical for sterile products. The FDA identified similar GMP violations at two other facilities within the company’s network. Both facilities were inspected in 2025 and 2026 and both were classified as Official Action Indicated. The agency noted that these facilities are in unacceptable CGMP status. The repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate according to the FDA letter.
Next we turn to Tianjin Kilo Pharmaceutical Sci-tech Co. Ltd. in Tianjin China. The company received a warning letter for significant deviations from current GMPs in its manufacturing of APIs and pharmaceutical intermediates. The violations were uncovered following an FDA request for records. The company produces chlorambucil a chemotherapy medication and demecarium bromide a product for treating glaucoma. Investigators stated that the company failed to demonstrate that its manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. This is a fundamental requirement of process validation.
Despite the company stating that the APIs were still under development and not yet commercial products the agency noted that formal documents such as standard operating procedures had not been finalized. However APIs were distributed to 503A compounding pharmacies. FDA said the company also failed to prepare and use master production and control records. The agency emphasized that without suitable batch records one cannot adequately monitor and analyze both intra-batch and inter-batch variations. This analysis is crucial to ensure that manufacturing processes remain in a state of control. Consequently the agency placed all products from the company on an import alert on 21 July 2026. This alert allows FDA officials to detain shipments without physical examination at the border.
The third case involves K.C. Pharmaceuticals in Pomona California. The FDA letter indicated that the company has not learned from its previous mistakes in manufacturing sterile eye drops. The company continued to manufacture and release its sterile drug products despite experiencing media fill failures in June September and November of 2024. A media fill is a critical quality procedure used to validate aseptic processing. It involves filling containers with nutrient broth instead of the actual product to simulate production. The company also lacked timely and adequate media fill investigations. Its root cause investigations were unsupported and lacked effective corrective actions.
Investigators observed poor practices and behaviors in ISO 5 areas during commercial operations and media fills. This includes operators inserting their upper torso into the RABS during interventions which breaches the ISO 5 barrier. In addition an operator performed a RABS intervention directly with the RABS system instead of using forceps. The company's quality unit failed to establish and follow procedures including procedures for handling customer complaints and inquiries. The company's approach to determining the severity and reporting of adverse events led to delayed and incomplete investigations. FDA said similar violations were cited in a previous warning letter issued on 3 August 2023. The agency stated that the recurrence of these violations demonstrates that the firm's corrective actions were neither effective nor durable.
Finally the FDA issued a warning letter to Safrel Pharmaceuticals a manufacturer in Dayton New Jersey. The agency cited the company for the absence of a quality control unit in all facets of manufacturing. The company holds labels and releases and distributes OTC drug products under its own label. It also manufactures prescription medications including pain relievers fever reducers and products for allergy and cold relief. The agency stated that the company lacks adequate quality unit oversight and procedures for the drug products it distributes. During the inspection the company revealed that there is no QU oversight for its suppliers and contract manufacturers including packagers. There was a noted absence of procedures outlining how the company ensures that the drug products received meet quality specifications. Additionally the company does not request receive or maintain Certificates of Analysis for incoming bulk and finished OTC drug products.
Furthermore there are no procedures in place for drug distribution that would facilitate a recall if necessary. FDA reminded the company that drugs must be manufactured in accordance with GMPs. The agency stated that it is aware that many drug manufacturers use independent contractors such as production facilities testing laboratories packagers and labelers. FDA regards contractors as extensions of the manufacturer. The warning letter indicates that if violations are not addressed FDA may withhold the issuance of Export Certificates. Additionally the agency may delay the approval of new applications or supplements that list the firm as a drug manufacturer until all violations are fully resolved. These warnings serve as a reminder of the complexities of the global drug supply chain and the critical nature of manufacturing standards.
For a deeper look at the regulatory standards and specific letter details you can visit the Regulatory Affairs Professionals Society resource page for this topic.
First reported by RAPS.
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