Drug factory · FDA FEI 3002486140
Linde Inc.
1225 South Front Street, Pekin, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 17, 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 |
|---|---|---|---|
| Carbon Dioxide | Makes it | Linde Inc. | 59578-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 17, 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.
Apr 17, 2014 inspection
- Correct labels during finishing operations 21 CFR 211.134(a)
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch.
Registered with FDA for: manufacture.