Drug factory · FDA FEI 1000126543
Seattle Children's Hospital
2525 220th Street SE, Suite 101, Bothell, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 2011.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Seattle Children's Hospital | 72740-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 25, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 25, 2011 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels are used for drug products are not written. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: manufacture.