Drug factory · FDA FEI 3017111
Oxarc, LLC
1004 E Mead Ave, Union Gap, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 24, 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 |
|---|---|---|---|
| Air | Makes it | Oxarc, LLC | 34057-006 |
| Nitrogen | Makes it | Oxarc, LLC | 34057-014 |
| Nitrous Oxide | Makes it | Oxarc, LLC | 34057-010 |
| Oxygen | Makes it | Oxarc, LLC | 34057-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 24, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
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 24, 2011 inspection
- 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. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices. - Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers and drug products and to prevent contamination. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance, cleaning, and inspection of equipment. - 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. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, and handling of drug product containers.
Registered with FDA for: manufacture.