Hospira, Inc.
Registered Address: Kansas, USA (USA)
5 Questions to Ask Hospira, Inc. Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: On 2026-03-10, FDA cited FDCA 501(a)(2)(A) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-03-10, FDA cited 21 CFR 211.122(d) (Personnel GMP Training, Gowning & Hygienic Practices). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-03-10, FDA cited 21 CFR 211.194(a)(2) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 1925262?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
FDA Form 483 issued to Hospira, Inc. (FEI 1925262) on 2026-03-10 following an inspection of its drug product manufacturer operations in Kansas. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Personnel GMP Training, Gowning & Hygienic Practices.
- FDCA 501(a)(2)(A) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window. REPEAT OBSERVATION
- 21 CFR 211.122(d) (Personnel GMP Training, Gowning & Hygienic Practices): Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
- 21 CFR 211.194(a)(2) (Finished Product Testing, Stability & Expiration Dating): Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
- 21 CFR 211.170(b) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
- 21 CFR 211.198(a) (CAPA, Out-of-Specification (OOS) & Complaint Investigations): Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
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Score Provenance Receipts
Every point in this facility's FDA Record Index (68/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-03-10 | -8.6 pts | INSP-483-1925262-20260310 ↗ |
| Form 483 (5 observations, 1 repeat) | 2026-03-10 | -15.5 pts | 483-1925262-20260310 ↗ |