Akorn’s warning letter reveals 'inadequate' investigations into manufacturing issues

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Aramyan)
(Image: Getty/Aramyan)

Related tags: Akorn, Fresenius, Fda, Warning letter

The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.

Akorn revealed that it received a warning letter​ for its Somerset, US, plant prior to the US Food and Drug Administration (FDA)’s publication of the details​.

The company’s CEO, Douglas Boothe, suggested that a “companywide action plan” ​would be undertaken to address the ‘timing and effectiveness’ of its systems.

In the warning letter, the FDA noted that ‘timings’ were a particular issue in regard to addressing manufacturing issues, outlining that “numerous investigations were open for more than six months; some were open for more than a year.”

In addition, the agency stated that such investigations were “inadequate and incomplete,”​ and did not result in “scientifically-supported conclusions.”

The FDA provided an example whereby an out-of-specification osmolality result, discovered during an 18-month stability test of ketorolac tromethamine ophthalmic solution, 0.5%, resulted in an ‘inadequate’ investigation.

The letter states, “[Akorn] concluded the event was an isolated incident with no complaints received for the product. However, we identified several complaints [Akorn] received for empty or leaking drug products for lots packaged in the implicated bottles.”

The FDA continued to identify that the bottle supplier had informed Akorn that bottle damage likely occurred during tip insertion onto the filling line; however, the company failed to conduct a ‘meaningful’ evaluation of this and other potential causes occurring on the processing line.

Further than this, the agency highlighted that the firm had failed to ensure that only authorized personnel could make changes to master production and control records. Inspectors also noted that employees failed to perform aseptic processes designed to prevent microbiological contamination of sterile drug products.

Issues grow for Akorn

This is the second warning letter that Akorn has received from the FDA this year, after a previous warning was issued regarding its Decatur, US. facility​. During this inspection, the agency also noted that sterile practices were not being followed.

The manufacturing issues outlined in these warning letters was key to the failure of the proposed merger between Fresenius and Akorn​ last year.

The failure of the deal to close saw Akorn’s then CEO, Raj Rai, retire from the company, after the share price of the company had fallen significantly to be worth $4.85, as of the time of writing. When the merger deal was announced, Akorn’s share price stood at $33.

Related topics: Regulatory & Safety, Regulations, QA/QC

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