Drug factory · FDA FEI 3010166452
Ross Healthcare, Inc.
Delta, Canada
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Serious problems, FDA action at FDA's last inspection, Jun 16, 2017.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
1 drug inspection on record since 2017: 0 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluoride Ion | Makes it | Ross Healthcare, Inc. | 62007-001, 62007-002, 62007-004 +27 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2017 | Serious problems, FDA action | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 16, 2017 inspection
- Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been documented. - Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable test methods. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product. - Records of disposition of rejected material 21 CFR 211.184(e)
Records do not include the disposition of rejected labeling. - Accurate reproduction included 21 CFR 211.188(a)
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed. - Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.