Drug factory · FDA FEI 1118580
Linde Gas & Equipment Inc.
8025 Dorsey Run Rd, Jessup, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 16, 2016.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2013: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Linde Gas & Equipment Inc. | 59579-002 |
| Oxygen | Makes it | Linde Gas & Equipment Inc. | 59579-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 27, 2013 | 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.
Dec 16, 2016 inspection
- 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.
Jun 27, 2013 inspection
- Ongoing verification - complaints, calibration records 21 CFR 123.8(a)(2)
Your verification procedures do not include, at a minimum, ongoing verification activities including review of consumer complaints, calibration of process monitoring instruments, and review of monitoring, corrective action, and calibration records. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
Registered with FDA for: manufacture.