FDA asks Dutch API producer to clean up its equipment law

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Posted on July 01, 2022 | By Joanne S. Eglovitch

FDA asks Dutch API producer to clean up its equipment law

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A Dutch producer of active pharmaceutical ingredients (APIs) has been warned to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the Food and Drug Administration (FDA) of the United States dated June 14. The FDA has found “visible powder residue” on non-dedicated equipment.

The warning letter pertained to the Fagron Group BV manufacturing site in Saint Paul, MN. The company is headquartered in the Netherlands.

Investigators found three good manufacturing practice (GMP) deficiencies following an inspection last November, including a failure to show that adequate cleaning studies had been carried out to prevent possible cross-contamination. The FDA said the company failed to conduct adequate cleanup validation studies during its API repackaging and relabeling operations for high potency drugs such as testosterone, estradiol, betamethasone, tamoxifen and opioids.

The company “was unable to provide a full cleaning validation study” to support its cleaning practices. “During the inspection, you acknowledged that your 2008 cleaning validation studies did not represent your current cleaning practices and that your cleaning procedures needed to be revalidated,” the FDA said.

Additionally, after the company said its cleaning validations were complete, investigators observed “visible powder residue on non-dedicated equipment” after progesterone repackaging.

The company also said it was unable to provide cleaning logs for its lidocaine HC1 repackaging, saying the logs had been “destroyed”.

The FDA said the company also failed to adequately investigate and document the out-of-specification results. For example, even though a June 2020 production of an API showed a high bioburden count, the company did not open an investigation into its water systems, which is a component used to manufacture the drug. .

Finally, the FDA said the company had a low quality unit (QU); investigators found that computers connected to CGMP-related lab equipment allowed changes to be made to the data supporting release of the drug without restrictions.

Additionally, the company acknowledged that its QU did not qualify the contract labs used to support product release, blaming the failure on “resource issues.” Still, the FDA said this violation was a repeat observation from its 2017 inspection. FDA warns Mexican over-the-counter drug maker, Dutch drugmaker and San Francisco Device CompanyRegulatory guidance September 18, 2018)

The FDA asked the company to consult the International Council for Harmonization (ICH) Q7 guidelines on GMP for APIs. The agency also advised him to hire a GMP consultant.

The company must submit a plan to address these deficiencies within 15 days of receiving the letter, and the FDA has warned that failure to correct these violations could cause the agency to withhold export certificates or suspend approval of new drug applications and supplements listing the company as a manufacturer. .

FDA warning letter

© 2022 Society of Regulatory Affairs Professionals.


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