Drug factory · FDA FEI 3011506656

Sina Health Inc

10769 N. Frank Lloyd wright Blvd. Suite A-110, Scottsdale, AZ, United States

Problems found, fixed voluntarily at FDA's last inspection, Jan 13, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2017: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jan 13, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	4
Apr 25, 2017	No problems found	Drug Quality Assurance	7

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit.
Examination of issued labels 21 CFR 211.125(b)
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.
Review of representative number of batches 21 CFR 211.180(e)(1)
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.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of light so that their identity, strength, quality, and purity are not affected.
Review of representative number of batches 21 CFR 211.180(e)(1)
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.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: relabel; repack.