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Interquim, S.A., at Barcelona received US FDA warning letter.

The U.S. FDA inspected drug manufacturing facility, Interquim, S.A., at Barcelona, in May 2016, and issued a warning letter, dated 22 November 2016. The summarized significant deviations from CGMP for API’s are as following,

1. Failed to establish adequate cleaning procedures which can define and justify acceptance criteria for residues.
2. Failed to construct equipment to avoid alteration of API quality beyond established specifications.
3. Failed to establish stability data to support retest or expiry dates and storage conditions.

Firm has to provide its response within 15 working days, specifying the activities performed to correct the violations and deviations and to prevent their recurrence. FDA recommended the firm to retain a qualified consultant to assist in remediation. Until all the violations and deviations are corrected completely, FDA may withhold approval of any new applications or supplements listing the firm as a drug manufacturer.


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