Drug factory · FDA FEI 1000125898
Olympic Ambulance Inc. DBA Olympic Oxygen Service
601 W Hendrickson Rd., Sequim, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2012.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Olympic Ambulance Inc. DBA Olympic Oxygen Service | 58498-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 13, 2012 inspection
- 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. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - 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.
Feb 18, 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. - Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Written procedures not followed 21 CFR 211.122(a)
Written procedures for the receipt, identification, and examination of packaging and labeling materials are not followed. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not described in a written procedure. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced. - Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. - 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. - 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.