Right Value Drug Stores LLC
Registered Address: 8400 Esters Blvd Ste 190, Irving, TX (United States)
5 Questions to Ask Right Value Drug Stores LLC 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 2026-09-08, FDA cited 21 CFR 211.100(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?
- Q2: On 2026-09-08, FDA cited 21 CFR 211.68(b) (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 2026-09-08, FDA cited 21 CFR 211.113(b) (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?
- Q4: Regarding Recall D-0070-2027 (Class II 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 Right Value Drug Stores LLC (FEI 3010589333) on 2026-09-08 following an inspection of its outsourcing facility operations in Texas. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Personnel GMP Training, Gowning & Hygienic Practices.
- 21 CFR 211.100(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 211.68(b) (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 211.113(b) (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.
- 21 CFR 211.113(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation. REPEAT OBSERVATION
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 2026-09-08 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 (28/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-09-08 | -9.7 pts | INSP-483-3010589333-20260908 ↗ |
| Form 483 (4 observations, 1 repeat) | 2026-09-08 | -14.5 pts | 483-3010589333-20260908 ↗ |
| Warning Letter (Open) | 2026-07-15 | -28.0 pts | CMS-684102 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0070-2027 ↗ |