Drug factory · FDA FEI 3007869619
Zydus Hospira Oncology Private Limited
Plot No.3, Pharmez, Special Economic Zone, Sarkhej Bavla Highway, Village Matoda, Taluka Sanand, Ahmedabad, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 30, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2012: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bleomycin | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0323, 0409-0332, 61703-323 +1 |
| Bortezomib | Makes it, tests it, packages it and labels it | Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. | 70771-1708, 70710-1411 |
| Cytarabine | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-155, 61703-304, 61703-305 +1 |
| Docetaxel | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0016, 0409-0201, 0409-0365 +8 |
| Gemcitabine | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0181, 0409-0182, 0409-0183 +3 |
| Idarubicin | Makes it, tests it, packages it and labels it | Pfizer Laboratories Div Pfizer Inc | 0013-2576, 0013-2586, 0013-2596 |
| Irinotecan | Makes it, tests it, packages it and labels it | Hospira, Inc., Pharmacia & Upjohn Company LLC | 61703-349, 0009-0082, 0009-0112 +1 |
| Mitoxantrone | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-343 |
| Oxaliplatin | Makes it, tests it, packages it and labels it | Hospira, Inc. | 61703-363 |
| Pemetrexed | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0004, 0409-0020, 0409-0021 +3 |
| Pentostatin | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0801 |
| Topotecan | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0302 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 30, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 12, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 16, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2012 | 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.
Oct 22, 2019 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - 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. - Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Apr 12, 2018 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Registered with FDA for: analysis; label; manufacture; pack.