Drug factory · FDA FEI 3009685660
Steriscience SP Z O O
Ul Daniszewska 10, Warszawa, Poland
Problems found, fixed voluntarily at FDA's last inspection, Feb 9, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 0 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aprepitant | Makes it, tests it, packages it, labels it and sterilizes it | Steriscience Specialties Private Limited | 82449-231 |
| Bicarbonate Ion | Makes it, tests it and packages it | Caraco Pharmaceutical Laboratories, Ltd., Steriscience Specialties Private Limited | 70095-050, 82449-000 |
| Doxycycline | Makes it and tests it | Steriscience Specialties Private Limited | 82449-008 |
| Methylene Blue Cation | Makes it, tests it, packages it, labels it and sterilizes it | Amneal Pharmaceuticals LLC, Steriscience Specialties Private Limited | 70121-2715, 70121-2716, 82449-002 +1 |
| Rocuronium | Makes it, tests it and packages it | Steriscience Specialties Private Limited | 82449-001 |
| Vancomycin | Makes it and tests it | Steriscience Specialties Private Limited | 82449-005, 82449-006, 82449-007 |
| Ziprasidone | Makes it and tests it | Steriscience Specialties Private Limited | 82449-004 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 9, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2014 | Serious problems, FDA action | Drug Quality Assurance | 12 |
| Sep 13, 2012 | Problems found, fixed voluntarily | 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.
Feb 14, 2014 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not reviewed and approved by the quality control unit. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - 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. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed. - 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. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.