This week FDA posted two warning letters to device manufacturers and two to drug manufacturers.

One of the drug manufacturers produces homeopathic drugs, which continues FDA’s focus on this area of the industry. The other drug manufacturer, located in India, was cited for failures to ensure the quality of recovered solvents. This is reminiscent of warning letters from last year that identified recovered solvents as being one of the potential sources of nitrosamine contamination in “sartan” drug products.

Drug Warning and Untitled Letters

Washington Homeopathic Products, Inc.

Washington Homeopathic Products, Inc. (Berkeley Springs, WV) received a warning letter on June 19, 2020, based on the outcome of an inspection ending July 2, 2019. In addition to adulteration, the FDA deemed that the firm is distributing unapproved new drugs. Consistent with recent warning letters to manufacturers of homeopathic drugs, FDA expressed concern because many of the products are labeled to contain potentially toxic ingredients. FDA says the firm’s Quality Systems are inadequate and recommends they hire qualified consultants to assist them in coming into compliance with regulations.

Deficiencies include but are not limited to:

  • The firm does not provide adequate Quality oversight for the drug products and components they receive, manufacture, or distribute. The firm admitted they failed to identify roles and responsibilities with their suppliers. The firm acquired a component/product that had been placed on Import Alert 66-40 and continued to distribute it.

  • Purchased raw materials were not testing for identity before release to manufacturing. The firm’s response was to perform a risk assessment to address this failure. FDA states “It is unclear in your response how your risk assessment would address drugs manufactured without appropriate raw material testing.”  

  • The firm did not adequately validate analytical methods for raw material testing and also for drug product testing

Vega Life Sciences Private Limited

Vega Life Sciences Private Limited (Telangana, India) received a warning letter on June 17, 2020, based on the outcome of an inspection ending November 28, 2019. The firm is a contract solvent recovery facility for API manufacture. It will be interesting to see if there is FDA follow up at the API sites which contract with this firm for solvent recovery. FDA suggests the firm hire a qualified consultant to assist them in coming into GMP compliance. Further, the firm was placed on import alert on April 14, 2020.

Deficiencies include but are not limited to:

  • Failure to establish and follow procedures to control impurity risks in solvent recovery. For example, the firm did not use standards in GC testing of solvents and they failed to establish an impurity profile for recovered solvents or investigate unknown peaks that were apparent in chromatograms. During the inspection, the firm provided investigators with a letter stating they had terminated processing recovered solvents for customers, but it is not clear that they would permanently cease this operation. 

  • The cleaning of shared equipment used in solvent recovery is inadequate.  Also, no records are available to document the cleaning of the non-dedicated equipment. The firm’s response was not adequate because it did not include a thorough evaluation that would ensure equipment was properly cleaned. 

  • Failure to exercise controls over computerized systems to ensure the integrity of the data generated by the firm including (but not limited to) missing raw data files, shared passwords and username, failure to back up data from stand-alone equipment, procedures governing audit trail management. 

Device Warning and Untitled Letters

Greiner Bio-One North America Inc

Greiner Bio-One North America Inc (Monroe, NC) received a warning letter on April 16, 2020, based on the outcome of an inspection ending December 13, 2019.  The firm manufactures Vacuette brand blood collection tubes. 

Deficiencies identified in the warning letter include but are not limited to:

  • The firm did not complete validation testing prior to the release of the product made to qualify a new supplier. The “draw volume” testing was not completed before the new material was released for use in manufacturing. 

  • The firm does not adequately manage complaints. Four device failures from June 2019 were not entered into the complaint system.

  • The molding machine used to manufacture the collection tubes was not validated. The warning letter identifies several shortcomings in the PQ activity.

  • Procedures for implementing CAPA activities are not adequate. For example, a CAPA to address validation of the manufacturing process and software validation did not include data required to demonstrate that requirements were met. 

  • The firm did not establish procedures to ensure that finished devices met requirements.

  • The calibration statuses of instruments used in manufacture were overdue for calibration. 

  • Quality Agreement did not specify responsibility for design validation.

  • Sampling plans are not statistically justified. 

  • The firms did not submit adequate MDRs, and thus products are deemed misbranded. 

Luminex Corporation

Luminex Corporation (Austin, Texas) received a warning letter on June 26, 2020, based on the outcome of an inspection ending February 14, 2020. The firm manufactures microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or research use including software and hardware. Deficiencies include but are not limited to:

  • Failure to validate, review, and approve a manufacturing change for the calibration heater test fixtures.

  • The firm has not followed its own SOP regarding CAPA actions.  Impacted product was not immediately contained after problems were identified.

  • Calibration and verification results for device servicing have not been kept since 2016. 

  • Quality requirements that must be met by suppliers were not established or maintained. 

  • FDA also deemed the VERIGENE SP Processor is misbranded because the firm failed or refused to furnish material or information regarding the device.

Letters to Compounding Pharmacies and Outsourcing Facilities

No letters were issued this week. 

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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