Drug factory · FDA FEI 3001238156
Therap-Ease Inc.
121 Industrial Park Rd, Plymouth, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 4, 2014.
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 2014: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Therap-ease Inc. | 63817-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2014 | 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.
Nov 4, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.