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FDA establishment 3011506656, Scottsdale, Arizona, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Jan 13, 2023
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.125(b). Examination of issued labels Labeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records.
21 CFR 211.100(a). Approval and review of procedures Written procedures are not reviewed and approved by the quality control unit.
Voluntary Action Indicated (VAI)
Apr 25, 2017
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of light so that their identity, strength, quality, and purity are not affected.
21 CFR 211.125(f). Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Scottsdale, Arizona, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.