Drug factory · FDA FEI 3002821211
Nutra-Med Packaging Inc.
Whippany, 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, Nov 20, 2024.
No Action Indicated: inspectors found no objectionable conditions.
12 drug inspections on record since 2010: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rizatriptan | Packages it | Exelan Pharmaceuticals, Inc. | 76282-462, 76282-463 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 20, 2024 | No problems found | Drug Quality Assurance | — |
| Nov 20, 2024 | No problems found | Drug Quality Assurance | — |
| Nov 22, 2021 | No problems found | Drug Quality Assurance | — |
| Nov 22, 2021 | No problems found | Drug Quality Assurance | — |
| Oct 11, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 11, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Jun 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Nov 5, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 2, 2010 | No problems found | Drug Quality Assurance | — |
| Sep 2, 2010 | 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.
Jun 29, 2016 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. - 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. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.