Drug factory · FDA FEI 3002821211
Nutra-Med Packaging LLC
118 Algonquin Parkway, Whippany, NJ, United States
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 |
|---|---|---|---|
| Atropine and Diphenoxylate | Packages it | Unichem Pharmaceuticals (USA), Inc. | 76385-107 |
| Diclofenac | Repackages it | Amici Pharma Inc. | 69292-548 |
| Dronabinol | Packages it | Ascend Laboratories, LLC, The Pharma Network LLC | 67877-753, 67877-754, 67877-755 +3 |
| Hydrocortisone | Packages it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-926 |
| Metyrosine | Packages it | Dr. Reddy's Laboratories Inc. | 75907-166 |
| Midodrine | Packages it | Xiromed, LLC. | 70700-157, 70700-158, 70700-159 |
| Pyrimethamine | Packages it and repackages it | Dr. Reddy's Laboratories Inc., TILDE Sciences LLC | 43598-672, 83649-330 |
| Rizatriptan | Packages it | Cipla USA., Inc. | 69097-865, 69097-866 |
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.
Registered with FDA for: label; pack; repack.