FDA warns drug, device makers for CGMP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug and device manufacturers for failing to meet its current good manufacturing practices (CGMP). Among the violations, the agency cited manufacturers for failing to ensure that final products met specifications, manufacturing machinery was sterile, and for failing to respond to potentially serious adverse event reports.

Abbott

FDA inspectors cited Abbott, one of the largest US-based global medtech companies, for several CGMP violations, including failure to maintain procedures to ensure its products met production specifications. The agency said the company failed to transfer performance specifications to a third-party manufacturer that produced its Freestyle Libre 3 continuous glucose meters (CGM).

More specifically, it noted that Abbott had established system design requirements that conform to regulations but failed to transfer those specifications to the third-party manufacturer or ensure it evaluated the finished products.

"Your firm failed to meet 21 CFR 862.1355(b)(3) special controls requirement that states: 'design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications,'" said FDA. "No controls were established at final product release to ensure finished products meet performance specifications.

"Additionally, DOC42469, Design Transfer Plan, Rev. D, does not describe how accuracy performance specifications derived from iCGM special controls are flowed down to external manufacturing sites or incorporated into their acceptance procedures," the agency added. "Contract manufacturers responsible for final assembly and release were not provided with accuracy performance requirements and were not required to verify finished-device accuracy performance prior to release."

Abbott was also cited for failing to maintain procedures to ensure that each production run, lot, or batch of finished products met acceptance criteria, and for failing to have procedures to identify statistical techniques to ensure process capability and product characteristics. It was also cited for failing to have design validation procedures to ensure that the final products meet user needs and intended uses.

FDA warned Abbott that if it did not take prompt steps to address the concerns raised by inspectors in the letter, it may take regulatory action.

“These actions include, but are not limited to, seizure, injunction, and civil money penalties,” said FDA. “Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

“Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed,” the agency added.

Flextronics

Austin, TX-based CGM maker Flextronics was also issued a warning letter from FDA for CGMP violations. Among the violations, the company was cited for failing to ensure that, when a manufacturing process can't be verified by subsequent inspections and tests, it is validated and approved in accordance with established procedures. It was also cited for failing to maintain procedures to implement corrective and preventive actions (CAPA).

"This cite is related to the quality problem identified in observation 1 where nonfunctioning devices were caused by improper alignment of the [redacted] leading to impact to the leads of the connector causing the [redacted] on the PCBA to break," said FDA. "After your firm opened a CAPA on 4/1/2025, it did not identify the actions needed to correct and prevent recurrence of broken components or [redacted] connections due to lack of defined specification for the [redacted].

"As a result, corrective maintenance requests to adjust the [redacted] continued after your corrective actions were initiated," the agency added.

Unomedical

FDA also issued a warning letter to Mexican medical device manufacturer Unomedical for CGMP violations. The company manufactures insulin infusion sets and was inspected through the agency’s Remote Regulatory Assessment program. It found that Unomedical failed to validate processes that could not later be fully verified during inspections and tests.

Furthermore, it was cited for failing to adequately investigate complaints that its products may not have met specifications and for not having adequate procedures in place to implement corrective and preventive actions.

Additionally, Unomedical was cited for not meeting the FDA's medical device reporting (MDR) requirements and failing to report credible incidents where its products may have caused serious injury or death within 30 days of being notified.

"For example, the information included for Complaint 1997347 reasonably suggests that four of your firm’s AutoSoft XC infusion sets malfunctioned (i.e. device leakage) during use, resulting in elevated blood glucose readings (hyperglycemia) that required the administration of a corrective bolus via the pump," said FDA. "We believe this medical intervention was necessary to prevent permanent impairment of a body function or permanent damage to a body structure.

"Therefore, each of these four events meets the definition of a reportable serious injury under 21 CFR 803.3," the agency added. "Your firm became aware of these events on September 4, 2024, but failed to submit the corresponding MDR for each of the four reportable serious injury events."

Cohance

FDA inspectors issued a warning letter to Indian drugmaker Cohance Lifesciences listing several CGMP violations, including failure to thoroughly investigate unexplained discrepancies or failures of final products that don't meet specifications, regardless of whether they have been distributed.

"Your investigations into drug-product quality issues were inadequate because they lacked thoroughness, adequate root-cause determination, and appropriate corrective action and preventive action (CAPA)," said FDA.

"For example, you received a customer complaint about [redacted] tablets USP [redacted] mg from two different batches that were reported to be crumbling, disintegrating, pitted, and with dust in the bottle," the agency added. "Your complaint investigation could not identify a root cause and concluded that the complaint was 'Not Substantiated.'"

Cohance was cited for failing to ensure its manufacturing process was clean and sterile to prevent potential contamination that could affect its final drug products, and for failing to have adequate written procedures for cleaning and maintaining equipment.

FDA inspectors also found stains within a duct and residue on a capsule-filling machine. The company's own analysis found that the stains and residues contained multiple active pharmaceutical ingredients (APIs) over the allowable limit.

"You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture multiple drug products," said FDA. "Your 2018 cleaning validation study failed to use the identified worst-case drug product, making it inadequate to ensure cleaning effectiveness.

"You also did not re-evaluate your cleaning validation program when introducing new drug products on shared manufacturing equipment, and you lack routine cleaning verification," the agency added. "Inadequate removal of drug residues during cleaning can cause cross-contamination in subsequently manufactured drugs on the same equipment."

Cohance notified FDA that it would temporarily suspend manufacturing and releasing drugs made at its manufacturing facility beginning in August 2025. In response, the agency asked the manufacturer to let it know when it plans to restart manufacturing drugs at the facility and to provide a summary of steps it has taken to remediate its issues and complete all its CAPA.

HTO Nevada

US-based contract manufacturer of over-the-counter drugs, HTO Nevada, was also cited for CGMP violations. Among the citations, its quality control unit (QU) was warned for failing to ensure its products complied with identity, strength, quality, and purity specifications, and the company was also cited for failing to have procedures in place to ensure those specifications are met.

"You lacked process validation data to demonstrate that you have adequately validated the manufacturing processes for drug products," said FDA.

"Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle," the agency added. "Each significant stage of a manufacturing process must be designed appropriately and must ensure the quality of raw material inputs, in-process materials, and finished drugs."

FDA noted that this wasn't the first time HTO Nevada had been cited for such CGMP violations and that, in the past, it had said it would take steps to remediate the problems but failed to do so. The agency recommended that the company get help from a qualified consultant to address its shortcomings.

While HTO Nevada said it would cease production at its facility, similar to its warning letter to Cohance, FDA asked the company if it plans to restart operations.

"If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations," said FDA. "You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance.

"In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA)," the agency added. "Additionally, you remain responsible for the products on the US market through their expiry date, which includes ensuring that you have adequate stability data to support these marketed products."

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FDA warns drug, device makers for CGMP violations

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