Greenwich Rx
Registered Address: 9733 Fm 2902 Rd. Suite 100, Tomball, TX (United States)
5 Questions to Ask Greenwich Rx 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 2026-09-09, FDA cited 21 CFR 211.192 (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-09-09, FDA cited 21 CFR 211.67(a) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-09-09, FDA cited 21 CFR 211.67(b) (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Regarding Recall D-0084-2027 (Class I on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
- Q5: 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?
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 Greenwich Rx (FEI 3043120213) on 2026-09-09 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
- 21 CFR 211.192 (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
- 21 CFR 211.67(a) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
- 21 CFR 211.67(b) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
FDA Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
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.
Following the 2026-09-09 inspection, our Quality Unit submitted a comprehensive CAPA response with third-party FTIR identity validation protocols and updated batch production records within 12 business days. All corrective actions are complete and verified.
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 (24/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-09-09 | -9.7 pts | INSP-483-3043120213-20260909 ↗ |
| Form 483 (3 observations, 0 repeat) | 2026-09-09 | -8.7 pts | 483-3043120213-20260909 ↗ |
| Warning Letter (Open) | 2025-12-10 | -24.4 pts | CMS-684101 ↗ |
| Recall (Class I) | 2026-10-28 | -24.9 pts | D-0084-2027 ↗ |