Drug factory · FDA FEI 1419377
Woodstock Sterile Solutions, Inc.
2210 Lake Shore Drive, Woodstock, IL, United States
No problems found at FDA's last inspection, Oct 13, 2022.
No Action Indicated: inspectors found no objectionable conditions.
11 drug inspections on record since 2009: 7 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azithromycin | Makes it, tests it, packages it and labels it | Thea Pharma Inc. | 82584-307 |
| Bromfenac | Makes it, tests it, packages it and labels it | Caraco Pharmaceutical Laboratories, Ltd. | 49708-754, 49708-755 |
| Budesonide | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 0115-1687, 0115-1689 |
| Cromolyn | Makes it, tests it and packages it | Rising Pharma Holdings, Inc. | 16571-600 |
| Dorzolamide and Timolol | Makes it | Akorn | 50383-261 |
| Iodine | Makes it | Alcon Laboratories, Inc. | 0065-0411 |
| Sacrosidase | Makes it | QOL Medical, LLC. | 67871-111 |
| Tobramycin | Makes it, tests it, packages it and labels it | Genericus, Inc., Pari Respiratory Equipment, Inc. | 70644-899, 24492-850 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 13, 2022 | No problems found | Drug Quality Assurance | — |
| Jul 3, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 22, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 16, 2013 | No problems found | Drug Quality Assurance | — |
| May 7, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 20, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 10, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 24, 2009 | No problems found | Drug Quality Assurance | — |
| Mar 2, 2009 | No problems found | Drug Quality Assurance | — |
| Jan 14, 2009 | 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, 2012 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of components for testing or examination.
Registered with FDA for: analysis; label; manufacture; pack; repack.