Week of June 23rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations.  The two drug warning letters are for non-prescription drug products, one over-the-counter (OTC) and one homeopathic located in China and India, respectively.

Akorn announced that they received a warning letter for the inspection last summer at their Somerset, NJ facility, their second warning letter of the year.  There is a precipitating 22-page form 483 for the as yet unpublished warning letter.  In February 2019, they received a warning letter for their site in Decatur, IL that was sent to their CEO in Lake Forest IL.  We’ll watch for publication of the new warning letter and will cover it when it is available.  

Also, the FDA issued two warning letters to sites commercializing unapproved kratom drug product: Kratom NC and Cali Botanicals, LLC.  For additional information, see the FDA press release.

 

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DRUGS | Rxhomeo Private Limited

Rxhomeo Private Limited (Telangana, India) received a warning letter on June 13, 2019, based on the outcome of an inspection ending February 1, 2019.  The firm manufactures homeopathic drugs, a hot-button area for FDA enforcement in the past couple of years.

This warning letter identifies that the firm used toxic materials for drug product manufacture without adequate controls, a theme for which other firms of this type have been cited. The firm was placed on import alert 66-40 on May 22, 2019, and the FDA recommends they employ qualified GMP consultants to assist them in coming into compliance.

Deficiencies include but are not limited to:

  • Incoming components were not tested for identity or other quality attributes.  The results in the Certificates of Analysis have not been verified for accuracy. 
  • A component on the homeopathic drug contains a “…highly toxic well studied poison that is used as a rodenticide.”
  • Batch records lack detail such as line clearance, the identity of major equipment, batch-specific information for components, a statement of yield, identification of individuals who performed and verified each operation.  Further, all homeopathic drug products share a single batch record.
  • The Quality unit failed to provide adequate oversight nor are the structure, function, and responsibilities described in a procedure.  The warning letter provides a long list of activities not performed by the Quality Unit.

DRUGS | Xi’an Livingbond Nonwoven Products Corp., Ltd.

Xi’an Livingbond Nonwoven Products Corp., Ltd. (China) received a warning letter on June 10, 2019, based on the outcome of an inspection ending January 10, 2019.  The firm manufactures Antibacterial Wet Wipes, OTC products. 

In addition to the GMP problems, the products are also deemed misbranded.  FDA recommends the firm employ a GMP consultant to assist them in coming into GMP compliance.  The firm was placed on import alert on April 12, 2019.

Deficiencies include but are not limited to:

  • FDA states that the firm’s Quality Systems are inadequate.
  • The firm did not test finished drug product before releasing for distribution.
  • The firm failed to test incoming API and other components, but rather, they relied on the supplier’s CoA but have not established the validity of the supplier’s data.
  • The firm has not validated their manufacturing processes and does not have a program to conduct ongoing monitoring to ensure the processes remain in a state of control.
  • The firm lacked an adequate quality unit and was missing basic procedures for GMP activities.

DEVICES | International Hospital Products, Inc.

International Hospital Products, Inc. (Littleton, CO) received a warning letter on May 29, 2019, based on the outcome of an inspection ending March 19, 2019.

The firm manufactures Class II devices.  The nine deficiencies identified in the warning letter suggest that the firm was not well informed or understood the requirements in 21CFR 820.

Deficiencies include but are not limited to:

  • The firm did not provide documented procedures to meet process validation requirements.  They were unable to provide documentation for sterilization.
  • While the firm does visually inspect incoming devices, they could not identify the defects that were evaluated/considered, nor are records available to document sterility of the lots that are currently being distributed.
  • The firm does not have procedures for evaluating suppliers for contract manufacture or sterilization of Class II devices labeled as sterile.
  • The firm could not provide a Device Master Record.
  • The firm does not have a procedure governing design changes.
  • The firm does not have a complaint handling procedure.
  • The firm could not demonstrate how Device History Records are maintained.
  • There is no procedure for controlling product that does not conform to specified requirements.
  • The firm does not have a procedure for Quality audits.

 

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