Gobiquity, Inc.
Registered Address: Tennessee, USA (USA)
5 Questions to Ask Gobiquity, 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 2026-02-12, FDA cited 21 CFR 212.20(d) (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 2026-02-12, FDA cited 21 CFR 212.71(c) (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?
- Q3: On 2026-02-12, FDA cited FDCA 505-1(f)(3)(A) (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?
- 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 3010539401?
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 Gobiquity, Inc. (FEI 3010539401) on 2026-02-12 following an inspection of its manufacturer operations in Tennessee. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
- 21 CFR 212.20(d) (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 212.71(c) (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.
- FDCA 505-1(f)(3)(A) (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 211.105(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 211.122(d) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims. REPEAT OBSERVATION
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
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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) | 2026-02-12 | -8.5 pts | INSP-483-3010539401-20260212 ↗ |
| Form 483 (5 observations, 1 repeat) | 2026-02-12 | -15.2 pts | 483-3010539401-20260212 ↗ |