FDA cites firm for failing to document adverse event investigations

By Hank Schultz

- Last updated on GMT

©Getty Images - serggn
©Getty Images - serggn

Related tags regulations Adverse events Warning letter

A recent warning letter reiterates the importance of collecting adverse event reports in order to demonstrate full compliance with federal laws governing the manufacture and sale of dietary supplements.

The US Food and Drug Administration sent a warning letter to a company called BHP Holdings, which does business as BIoPure Healing Products, which is based in Woodline, WA.  Despite the fact that the company claims to have been in business since 2008, according to the warning letter​, it does not have its adverse event reporting ducks in a row.

According to FDA, BHP made the following errors concerning complaints the company had received:

Burning throats, ‘allergic’ reaction reported

“[D]uring our inspection, a review of product complaints found that you failed to follow your procedures to investigate product complaints related to adverse events, including a complaint received on April 26, 2018, reporting burning of mouths and throats; a complaint received on January 10, 2019, reporting ‘customers’ experiencing nausea, stomach aches, headaches, and some rashes; and another complaint from January 10, 2019, reporting an ‘allergic’ reaction, in order to identify root cause,”​ the agency said.

In the text of the amended warning letter the agency said it had reviewed BHP’s response to the initial 483 observations concerning BHP’s adverse event reporting practices. Those included documentation of the company’s use of official complaint forms. 

At first glance, the conditions described in the customer complaints would seem to fit the bill for a ‘serious’ adverse event.  According to FDA​, such conditions can include:

  • itching, rash, hives, throat/lip/tongue swelling, wheezing
  • low blood pressure, fainting, chest pain, shortness of breath, palpitations, irregular heart beat
  • severe, persistent nausea, vomiting, diarrhea, or abdominal pain
  • fatigue, appetite loss, yellowing skin/eyes, itching, dark urine
  • abnormal bleeding from nose or gums
  • visit to Emergency Room or hospitalization.

Investigaiton details needed to support conclusions

In its response to the findings of the initial inspection, which lasted from Oct. 15 through Nov. 8, 2019, the company said it had determined the above incidents were not ‘valid’ complaints, and therefore were not of the sort that must be forwarded on to FDA. The agency, however, said it still had concerns about how BHP arrived at its determination that the events were not valid.

“Each of the Forms F-4010A for these three complaints have it noted that the complaints are not valid, and that an investigation is only required when a complaint is valid.  These complaint forms lack the investigation details to determine how the safety risk of the products were assessed. According to the procedure in your response, a Corrective and Preventative Action (CAPA) is required to address root causes of complaints, but no CAPA appears to have been opened for these three complaints,”​ the warning letter noted.

Adverse event reporting key part of compliance

Rick Kingston, PharmD, is president of scientific and regulatory affairs atSafetyCall International, which helps companies in several industries manage their adverse events reporting.  Kingston is also a professor in the School of Pharmacy at the University of Minnesota.  Kingston said adverse event reporting is a critical piece of dietary supplement post market surveillance and as such is taken very seriously by FDA.

“It’s not surprising that they would be clamping down on companies that are disregarding their responsibility.  It emphasizes the importance of having a robust adverse events system in place so that you don’t have these kinds of problems with the agency,”​ he said.

BHP Holdings did not respond to a request for comment in time for publication.

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