FDA hands drugmaker, diagnostics firm warning letters for GMP violations

The US Food and Drug Administration (FDA) has issued warning letters to a drugmaker and a diagnostics company for failing to meet its current good manufacturing practices (cGMP) requirements. The agency cited the drugmaker for distributing ophthalmic drugs from a contract manufacturing organization (CMO) with poor hygiene practices, and the diagnostics company for failing to implement proper corrective and preventive actions (CAPA).

In a 13 May warning letter to New Jersey drugmaker AACE Pharmaceuticals, FDA noted that the company had distributed eye ointments from Indian CMO Brassica Pharma. In early 2024, Brassica was placed on an import alert, and its products were recalled after inspectors found it had failed to maintain proper sterile conditions, fabricated laboratory records, and other violations.

During a November inspection of AACE Pharmaceuticals’ facilities and its import records, FDA inspectors noted that the company was importing drugs from Brassica and distributing them in the US without proper controls. Inspectors said its quality control unit failed to ensure the redistributed drugs met cGMP requirements.

“Your firm utilized a CMO to manufacture your ophthalmic drug products,” FDA wrote. “However, your quality unit failed to have adequate supplier qualification procedures to ensure that the drug products received from your CMO were manufactured in compliance with CGMP before being distributed in the United States.”

While AACE Pharmaceuticals responded to FDA’s initial Form 483 stating that it had revised its procedures, the agency said it failed to provide sufficient details on how it plans to assess cGMP deficiencies. The agency said the procedures also don’t include a process to evaluate its other CMOs or disqualify CMOs that fail to meet requirements.

“In addition, you state that you will be comparing the data reported on the certificate of analysis (COA) against the pre-approved specification before releasing finished product,” according to FDA. “We note that your quality unit is ultimately responsible for ensuring that your drug products are manufactured in accordance with CGMP.

“Comparing a COA from a CMO to pre-approved specifications does not overcome your responsibility to evaluate, qualify, audit, and monitor your contract manufacturers,” the agency added.

On 5 May, FDA also sent a warning letter to Spanish X-ray maker Sedecal S.A. for GMP violations. The agency noted that the company initiated a CAPA after a report that its DXD100 mobile self-propelling X-ray unit crashed into an X-ray control panel and another report that it almost ran into a patient. However, inspectors say the company failed to document a risk assessment of the devices in use that are affected by the issue.

Sedecal was also cited for failing to establish proper device design validation procedures.

“Design validation shall include risk analysis, where appropriate,” FDA wrote. “Specifically, your firm conducted a recall to address unintended movement of MobileDiagnost wDR that could result in life-threatening situations and cause the device to stop working as intended. However, the risk analysis for MobileDiagnost wDR (Document IH0532RA_Annex, dated April 26, 2022) fails to include this increased hazard severity (life-threatening) to ensure that appropriate risk control measures are implemented.”

While Sedecal said it would revise its CAPA to ensure investigations are appropriately documented, personnel are adequately trained, and its recall is reevaluated, FDA said the responses were inadequate because they did not include the revised procedures and a retrospective review of related documents.

Sedecal was cited for several other GMP violations, including failing to submit a report of a device correction or removal and failing to conduct proper certification for its electronic products.

In both cases, FDA gave the companies 15 days to respond to the warning letters.

AACE Pharmaceuticals Warning Letter
Sedecal S.A. Warning Letter

FDA hands drugmaker, diagnostics firm warning letters for GMP violations

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