Drug factory · FDA FEI 3002772224
Reed-Lane, Inc.
359 Newark Pompton Turnpike, Wayne, NJ, United States
No problems found at FDA's last inspection, Oct 17, 2025.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2010: 6 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupropion | Packages it | Amneal Pharmaceuticals, Lifestar Pharma LLC. | 0115-6811, 70756-830 |
| Carbidopa and Levodopa | Packages it | Amneal Pharmaceuticals | 64896-661, 64896-662, 64896-663 +1 |
| Cetrorelix | Packages it and labels it | Akorn | 17478-793 |
| Digoxin | Packages it | Amneal Pharmaceuticals | 0115-9811, 0115-9822 |
| Fenofibric Acid | Packages it | Amneal Pharmaceuticals | 0115-5511, 0115-5522 |
| Glyburide | Packages it and labels it | Teva Pharmaceuticals USA, Inc. | 0093-9364, 0093-9433, 0093-9477 |
| Isotretinoin | Packages it | Dr.Reddy's Laboratories Ltd., JG Pharma Inc. | 55111-113, 55111-135, 55111-136 +5 |
| Orphenadrine | Packages it | Amneal Pharmaceuticals | 0115-2011 |
| Sevelamer | Packages it and labels it | Genzyme Corporation, Sanofi-Aventis U.S. LLC | 58468-0130, 58468-0131, 58468-0132 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 17, 2025 | No problems found | Drug Quality Assurance | — |
| Mar 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 25, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2016 | No problems found | Drug Quality Assurance | — |
| May 13, 2013 | No problems found | Drug Quality Assurance | — |
| May 11, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 30, 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.
Mar 3, 2023 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: label; pack; relabel; repack.