Drug factory · FDA FEI 1036650
International Laboratories, LLC
Seminole, Florida, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2015.
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 2010: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Montelukast | Repackages it and relabels it | International Laboratories, LLC | 54458-890 |
| Nifedipine | Repackages it and relabels it | International Laboratories, LLC | 54458-948, 54458-950 |
| Pioglitazone | Repackages it and relabels it | International Laboratories, LLC | 54458-864, 54458-865, 54458-866 +3 |
| Pravastatin | Repackages it and relabels it | International Laboratories, LLC | 54458-927 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 29, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 23, 2015 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Packaging line inspection before use 21 CFR 211.130(e)
Inspection of the packaging facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
Jan 29, 2010 inspection
- Lab controls established, including changes 21 CFR 211.160(a)
The establishment of specifications including any changes thereto, are not reviewed and approved by the quality control unit. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. - Inspection of packaging and labeling area 21 CFR 211.188(b)(6)
Batch production and control records do not include results of the inspection of the packaging and labeling area after use for each batch of drug product produced.