Drug factory · FDA FEI 1000524452
Lincare Inc.
6706 Martin Way E Suite 1, Olympia, WA, United States
No problems found at FDA's last inspection, Jun 19, 2014.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Transfills it | Lincare Inc. | 57800-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 19, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 25, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 6, 2012 | No problems found | Drug Quality Assurance | 3 |
| Feb 17, 2010 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 8, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 6, 2012 inspection
- 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. - Sampling and testing plans not followed 21 CFR 211.165(c)
Written procedures for sampling and testing plans are not followed for each drug product. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Jan 25, 2010 inspection
- Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet as a condition for their approval and release. - 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.
Apr 8, 2009 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control 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. - Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release. - 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. - 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: transfill.