Drug factory · FDA FEI 1831761
Lessors, Incorporated
1300 N Genesee Rd, Burton, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 29, 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 |
|---|---|---|---|
| Nitrous Oxide | Makes it | Lessors, Incorporated | 55404-002 |
| Oxygen | Makes it | Lessors, Incorporated | 55404-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 29, 2011 inspection
- Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: manufacture.