Fake Data, Failed Tests, and More: Four FDA Warning Letters to Pharma Firms Reveal Fundamental CGMP Problems
Manufacturing facilities in India, Texas, and Florida demonstrate how fundamental quality issues continue to plague both domestic and international pharma operations.
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The FDA is kicking off 2025 with warning letters revealing a few deeply concerning patterns across several pharma manufacturing operations. Our analysis focuses on four significant warning letters issued between January 29 and February 10, 2025, that expose systematic failures in both domestic and international pharmaceutical operations.
These warning letters target various facilities: two API manufacturers in India, a contract testing laboratory in Florida, and a finished pharmaceutical product manufacturer in Texas. Despite their different operations and locations, these facilities share a few alarming similarities in their quality system deficiencies.
Let’s quickly break down the patterns we’re seeing across these three letters.
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Data integrity failures
Arguably, the most alarming findings across these warning letters center on data integrity violations, which undermine the very foundation of QA.
At Tyche, multiple serious data integrity breaches were uncovered. Operators admitted to falsifying temperature data for a drying oven that wasn't even turned on during the manufacture of a batch. (The batch in question later failed residual solvents specifications.) Also, multiple quality personnel, including an Assistant Manager in Production, an Assistant Manager in Quality Assurance, and a Quality Control Manager, participated in creating a "backdated calculation sheet" specifically to present to FDA investigators. The FDA was not satisfied with the company’s company's response to these findings, as they proposed waiting nearly ten months to implement corrective actions for these serious data integrity violations.
At ABR Laboratory, data integrity issues were observed in equipment monitoring. Its 2-8°C refrigerator (which contained reference microorganisms used in growth promotion tests) exceeded its temperature range for over 24 hours, reaching temperatures up to 17.4°C. The deviation was neither identified nor investigated, calling into question the reliability of all microbiological testing performed using these reference materials. The lab's response failed to address how this oversight impacted previously released test results or how they would prevent similar failures in the future.
Equipment and cleaning validation
The warning letters also revealed concerning lapses in equipment maintenance and cleaning — the basics of CGMP.
At Tyche, FDA investigators found rust-like residues inside non-dedicated equipment used in API production. Bare footprints were also discovered inside equipment labeled "cleaned and ready for use." When confronted with these issues, the company claimed to have reviewed product quality since February 2024 but failed to explain why it limited its review to this timeframe or how it would prevent personnel from entering equipment without proper protection in the future.
While different in nature, ABR Laboratory's equipment control issues demonstrated similar systematic failures. Its critical lab equipment regularly operated outside specified parameters without detection or correction. Temperature excursions in its storage units potentially compromised reference materials essential for accurate testing. The laboratory's quality systems proved inadequate to detect these issues in real time, and it lacked proper systems for monitoring and alert notification. When asked about its equipment monitoring during the inspection, it couldn't provide evidence of any effectiveness evaluation for its control measures.
Testing and validation
Three of these facilities were cited for significant testing and validation deficiencies.
Texas-based rapheGenerics Corp, an OTC drugmaker owned by AmWiner & Raphe Holdings, showed multiple testing failures. The letter says the firm released drug products without adequate testing to confirm critical quality attributes and failed to test each shipment of propylene glycol for DEG and EG contamination. It also didn't perform identity testing on raw materials used in API production.
ABR Laboratory was cited for using unvalidated microbiological test methods that weren't proven equivalent to USP standards and failing to perform method suitability testing for OTC drug products, including those intended for children. The FDA said there was no demonstration that their test methods could reliably determine microbial contamination.
Tyche’s testing failures focused on incoming materials, with the company failing to test the identity of each batch of incoming production material. When this was discovered during the inspection, the response was inadequate — merely stating they had "initiated the activity" to test materials for identity but failed to address how they would prevent this deviation from recurring with new materials. The company also failed to properly qualify raw material suppliers or establish appropriate expiration or retest dates for materials.
Contract manufacturing and testing
When it comes to contractors and suppliers, we find ourselves saying the same thing in almost all of these warning letter breakdowns: responsibility cannot be outsourced. Yet again, these warning letters demonstrate that outsourcing manufacturing or testing doesn't mean outsourcing responsibility.
Jagsonpal Pharmaceuticals in India demonstrated significant oversight failures:
It used an unregistered contract manufacturing organization for API production.
It failed to ensure their CMO completed process validation.
It didn't verify that master production instructions were complete.
It initially refused FDA investigators entry to its facility.
It limited access to requested documents during the inspection.
As a contract testing laboratory, ABR Laboratory failed to validate test methods for its clients' products, maintain proper laboratory conditions, investigate OOS results, and properly oversee critical laboratory operations. The FDA emphasized that as a contract laboratory, they were considered an extension of their clients' manufacturing operations and were therefore required to maintain full CGMP compliance.
Quality unit authority
The warning letters consistently highlighted Quality Unit failures.
Tyche's Quality Unit was unable to ensure the integrity of CGMP records, failed to prevent known data falsification, and inadequately oversaw its manufacturing operations.
Jagsonpal's Quality Unit failed to exercise responsibility for ensuring API manufacturing compliance, properly oversee their contract manufacturer, ensure adherence to CGMP requirements, and maintain proper documentation systems.
A few questions for self-assessment
Having worked with pharma Quality teams on auditing, mock inspection, gap analysis, and remediation support, we can say that these warning letters highlight several critical areas where we find companies commonly fall short.
Ask yourself the following questions and contact us if you don’t know or don’t like your answers to any of them.
Data integrity
Could you show an FDA investigator, right now, complete audit trails proving who made changes to any quality record in the past month and why?
For your last 10 batch records, can you prove through metadata and audit trails that every entry was made at the time of the activity?
What would your trend analysis of equipment parameters from the last 3 months reveal about your ability to detect and respond to deviations?