Drug factory · FDA FEI 3009017204
Actavis LLC
47 Brunswick Ave, Edison, NJ, United States
No problems found at FDA's last inspection, Nov 22, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2012: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nortriptyline | Packages it and labels it | Mayne Pharma Inc. | 51862-015, 51862-016, 51862-017 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 22, 2024 | No problems found | Drug Quality Assurance | — |
| Aug 8, 2019 | No problems found | Drug Quality Assurance | — |
| May 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jul 7, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 29, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2012 | No problems found | 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.
May 7, 2018 inspection
- Labeling and packaging improperly approved/released 21 CFR 211.122(b)
Labeling and packaging materials not meeting the appropriate written specifications were released for use. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing and holding of a drug product lack the training and experience required to perform their assigned functions. - Quarantined Drug Products Area 21 CFR 211.42(c)(7)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Containers sampled so as to prevent contamination 21 CFR 211.84(c)(2)
Containers are not opened and sampled in a manner designed to prevent contamination of their contents.
Registered with FDA for: label; pack.