FDA cites drug firms for CGMP violations, failing to provide records
The US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.
Genzyme Ireland
FDA inspected Genzyme Ireland's manufacturing facility, which produces Thymoglobulin (Anti-thymocyte Globulin [Rabbit]) and Altuviiio (antihemophilic factor [recombinant]), last January and found significant CGMP violations.
Investigators stated that Genzyme's quality unit failed in its duties and listed examples, including failing to ensure that laboratory records included complete test data, failing to document test failures that showed non-viable particulates, and failing to properly document air monitoring samples.
"Your laboratory records were incomplete because quality control personnel used uncontrolled Review Checklists to unofficially document laboratory record reviews, which were subsequently discarded," said FDA. "Additionally, updates to your records were not always traceable or attributable to a specific person."
"These failures demonstrate a pattern in which your quality unit failed to exercise proper oversight, including oversight of your data integrity practices," the agency added. "Accurate and reliable data is necessary to ensure that your products meet established specifications for identity, strength, quality, and purity."
While Genzyme notified FDA that it had initiated corrective actions the agency said it failed to address the underlying failures of its quality unit to ensure CGMP compliance. The agency also said the company's corrective action plan wasn't comprehensive enough.
Wizcure Pharmaa
FDA also warned Indian drugmaker Wizcure Pharmaa for CGMP violations; in particular, its failure to ensure its laboratory records contained complete testing data. The company was cited for falsifying test data and laboratory forms.
"For example, our investigator observed [redacted] personnel monitoring microbial plates in your laboratory incubator with visible microbial growth," said FDA. "The next day, our investigator observed microbial plates with the same identification information with no growth.
"Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates," the agency added. "This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line."
The investigators also said that the company frequently failed to record environmental monitoring, personnel monitoring, and sample data. They also noted critical discrepancies in the company's sample test results and said it failed to reliably incubate samples and accurately record microbial counts.
"Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and [redacted] testing results), further demonstrating untrustworthy documentation," said FDA. "Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment."
Wizcure told FDA it had suspended manufacturing, initiated a remediation program, and engaged a third-party consultant to help it with its corrective actions. FDA, however, said the response did not sufficiently address the organizational causes of failures in data integrity practices.
Wizcure was also cited for failing to ensure manufacturing was conducted within defined areas of adequate size and for failing to follow proper written procedures to prevent microbiological contamination. Furthermore, the company was cited for failing to properly clean, maintain, and sanitize and/or sterilize equipment to prevent malfunctions and contamination.
"For example, your filling line was observed with apparent rust on the critical aseptic processing equipment, including the [redacted]," said FDA. "Also, our investigators observed stains and apparent rust on the HEPA filters and their diffuser grids above the filling line.
"We are concerned with your management’s lack of oversight of manufacturing operations that allowed insanitary equipment to be used in sterile drug manufacturing," the agency added. "An effective equipment management program requires a proactive lifecycle approach with systematic monitoring, maintenance, and timely replacement to ensure continued process capability."
FDA also said Wizcure's data integrity remediation was inadequate, and while the company said it was suspending manufacturing of certain over-the-counter drugs for the US market, the agency said it wants to be notified if it plans to resume manufacturing. Regulators said the company's executive management should assess its operations for compliance and recommended that it seek assistance from a qualified consultant.
Excelvision
French drugmaker Excelvision, a subsidiary of Fareva, was cited for CGMP violations, including failing to thoroughly investigate batch discrepancies and failures, and failing to have proper written procedures to microbiological contamination in its manufacturing process.
"We observed poor aseptic practices during and after the setup of your filling line [redacted] which is used in the manufacture of [redacted] drug products," said FDA. "In addition, the [redacted] equipment on this line was poorly designed.
"Your aseptic manufacturing processes should be designed, and operations executed, to prevent contamination hazards to your sterile product," the agency added. "Flaws in the design of cleanrooms and aseptic processing lines or improper execution of aseptic operations can promote influx of contamination into the critical processing area."
FDA said Excelvision failed to ensure the surfaces in its facility were easily cleanable to ensure the area was aseptic for processing products, and for failing to ensure its cleaning and disinfecting systems are sufficient to maintain aseptic conditions. The agency also noted that the company had previously received a warning letter for similar issues.
"In a previous warning letter (WL 320-25-70), FDA cited similar severe CGMP violations," said FDA. "The recurrence of these violations demonstrates that your firm’s corrective actions were neither effective nor durable.
"Notably, your failure to correct these issues led to unacceptable drug product being distributed to the U.S. market," the agency added.
Ultimately, FDA said Excelvision's quality system was ineffective and recommended the company engage a qualified consultant.
Yangzhou Hongshengding Chemical
FDA cited Chinese OTC drugmaker Yangzhou Hongshengding Chemical for failing to provide investigators with records as required by law. More specifically, the agency said it sent several requests for records and other information to the company via email, but did not get any responses.
"According to FDA records, your firm initially registered as a drug manufacturer in October 2016 and then had your registration switched to out-of-business in July 2019," said FDA. "FDA staff contacted your firm in July 2023 and were informed that your firm was still in business.
"Personnel from your firm stated at that time that you had not manufactured or shipped any drug products intended for the U.S. market in several years and did not have any future plans to do so," the agency added.
FDA noted, however, that the firm re-registered in 2025 as a drug manufacturer and resumed drug shipments to the US. Following the re-registration, regulators continued to ask the company for records, but to no avail.
"FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-79 on June 3, 2026," said FDA. "Until FDA can confirm your compliance with Current Good Manufacturing Practice and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
"In addition, shipments of articles manufactured at Yangzhou Hongshengding Chemical Co., Ltd., located at No. 8, Sitong Road, Hangji Industrial Park, Guangling District, Yangzhou, coming into the U.S. market that appear to be adulterated or misbranded are subject to being detained or refused admission, pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3)," the agency added.
