Drug factory · FDA FEI 3004582475
Acceleration Laboratory Services Inc.
2634 NE Hagan Road, Lee's Summit, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2009: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lofexidine | Tests it | Prasco Laboratories | 66993-345 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 12, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 26, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 25, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 11, 2024 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of apparatus, gauges and recording devices is not done at suitable intervals in accordance with an established written program. - No written record of investigation 21 CFR 211.192
Written records are not made of investigations into.
Registered with FDA for: analysis.