Drug factory · FDA FEI 1000120529
Lincare Inc.
10 Upton Drive Suites 11, 12 & 14, Wilmington, MA, United States
No problems found at FDA's last inspection, Jun 5, 2012.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2009: 1 with no problems, 1 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 5, 2012 | No problems found | Drug Quality Assurance | — |
| Dec 21, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 21, 2009 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance. - 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. - 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.
Registered with FDA for: transfill.