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Regulatory Focus™ > News Articles > FDA Warns Spanish API Maker for GMP Violations

FDA Warns Spanish API Maker for GMP Violations

Posted 06 December 2016 | By Michael Mezher 

FDA Warns Spanish API Maker for GMP Violations

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

In a warning letter, FDA cites Interquim for three issues related to its cleaning procedures, deteriorated equipment surfaces and stability testing data.

According to FDA, Interquim did not have adequate cleaning procedures for removing residues from equipment used to manufacture its API.

"Our investigator found that the interior surfaces of your non-dedicated drug manufacturing equipment [redacted] were not clean as required by your cleaning [standard operating procedures] SOP," FDA writes, citing the presence of a residue inside equipment that had been marked "clean."

While FDA says Interquim acknowledged the issue and revised its cleaning methods, the agency says the company's response was inadequate, as it did not demonstrate that the new cleaning procedures were effective. Additionally, FDA says Interquim "did not define the acceptance criteria for carryover of residues" in its new procedures.

FDA also says its investigator found that the interior surfaces of some of Interquim's equipment were discolored, and despite being recently repaired, that the company could not demonstrate that the materials used in the repair would not affect API quality.

Additionally, FDA says that the company failed to provide adequate stability data to support the retest or expiry dates and storage conditions for its products.

"Without stability data for your reprocessed API, you cannot assure that your reprocessed API meets specifications throughout its assigned shelf life. This could adversely affect the quality of the drugs that your customers manufacture from your API," FDA writes.


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