Drug factory · FDA FEI 2211563
Actavis Elizabeth LLC
Elizabeth, New Jersey, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
No problems found at FDA's last inspection, Jul 24, 2023.
No Action Indicated: inspectors found no objectionable conditions.
16 drug inspections on record since 2008: 8 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Diclofenac | Makes it | Actavis Pharma, Inc. | 0228-2551 |
| Inflammation Reduction Pack | Repackages it | TMIG, Inc. | 69176-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 24, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 5, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 25, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 15, 2013 | No problems found | Bioresearch Monitoring | — |
| Jan 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 26, 2011 | No problems found | Drug Quality Assurance | 6 |
| Apr 26, 2011 | Problems found, fixed voluntarily | Bioresearch Monitoring | 6 |
| Feb 18, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 4, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 22, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 18, 2008 | Problems found, fixed voluntarily | 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.
Apr 26, 2011 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, and evaluation of post marketing adverse drug experiences. - Failure to review ADE information 21 CFR 314.80(b)
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and reports in the scientific literature. - Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, and evaluation of post marketing adverse drug experiences. - Failure to review ADE information 21 CFR 314.80(b)
Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience and reports in the scientific literature. - Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. - Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.