Inspection Readiness Assessment Only — Not Legal or Regulatory Advice. Uploaded SOPs and batch records are private to your session and never used to train external models. Only anonymized clause-exposure statistics are retained for peer benchmarking.

ZERO CROSS-CUSTOMER TRAINING

PRODUCT 2 · AI MOCK FDA INSPECTION ($1,500–$5,000 ASSESSMENT ENGINE)

Grade Your Plant's SOPs & Batch Records Against the FDA Form 483 Corpus

Test the live grading engine below using one of our 4 pre-loaded SOP packets (including Dietary Supplement GMP, Jettal Food Plant FSMA Part 117 benchmark, Skincare MoCRA, or a Remediated 96/100 packet), or paste your own SOP text.

1-Click Pre-Loaded Test Packets:

Sample A: Gummy & Capsule Supplement Co-Packer SOP Packet (Typical Pre-Audit Gaps)Sample B: Food & Culinary Co-Packer Packet (21 CFR Part 117 FSMA & FSVP Check)Sample C: Skincare & OTC SPF Contract Manufacturer Packet (MoCRA & 21 CFR 211)Sample D: Remediated cGMP Gold-Standard SOP Packet (Post-Fix Verification — 96/100)

1. Configure Facility Regime & SOP Input

Facility Name

CFR Regulatory Regime

Simulate Specific FDA Investigator Focus

Uploaded / Pasted SOP, MMR, BPR & Sanitation Text

SOP-QA-004 (REV 4.2): INCOMING DIETARY INGREDIENT IDENTITY TESTING & SUPPLIER QUALIFICATION (21 CFR 111.75(a)(1)-(2))
1. 100% Identity Testing: Every incoming lot of dietary ingredients undergoes FTIR/NIR or HPLC identity testing in our ISO 17025 lab prior to release from Quarantine.
2. Supplier Qualification for Non-Dietary Components: No supplier COA is accepted unless the vendor has passed an on-site/virtual cGMP audit, signed a Quality Agreement, and passed 3 consecutive full-panel confirmatory lab verifications, with annual re-verification.

SOP-MMR-205 & BPR-260: MASTER MANUFACTURING & BATCH PRODUCTION RECORDS (21 CFR 111.205 / 111.260)
1. Controlled Master Manufacturing Record (MMR) locked per SKU and batch size with dual QA/R&D e-signatures (21 CFR Part 11 compliant).
2. Batch Production Record (BPR) captures barcoded raw lot numbers, tare/gross scale printouts, dual-operator sign-off on critical step additions, in-process weight/water-activity (Aw) checks, and theoretical vs. actual yield reconciliation (+/- 2.0% investigation trigger).

SOP-LAB-075 & STAB-166: FINISHED BATCH RELEASE & STABILITY PROGRAM (21 CFR 111.75(c))
1. Zero-Quarantine Release without CofA: Every finished lot is tested for active label-claim potency, USP <2021>/<2022> microbiology (TAMC, TYMC, E. coli, Salmonella, S. aureus), and USP <2232> elemental impurities (As, Cd, Pb, Hg).
2. Expiration dates are backed by ICH Q1A accelerated (40C/75% RH) and real-time (25C/60% RH) stability studies.

SOP-SAN-027 & CAPA-553: VALIDATED CLEANING, PEST EXCLUSION & CAPA/ADVERSE EVENT LOGS (21 CFR 111.27 / 111.553)
1. Equipment cleaning logs linked to prior/next batch numbers with ATP bioluminescence and allergen swab sign-off by QA prior to line clearance.
2. All OOS results, batch deviations, and consumer complaints/Serious Adverse Events (SAEs) trigger a formal 30-day root-cause CAPA investigation reviewed by the Quality Unit.

AI Mock Inspection Readiness Report

Lone Star Nutraceuticals & Gummy Works LLC

NAI Ready (No Action Indicated — Clean Audit Posture)

96/100

✓ Co-Packer Readiness Badge Unlocked!

Simulated Investigator Brief — Marcus V. Delgado (Southwest Division (Dallas District)): Focuses heavily on 21 CFR 111.75(a)(1)(i) and 21 CFR 111.205(a). Expect a request for your Approved Supplier List, raw component identity testing chromatograms, and last 24 months of OOS/CAPA logs within the first 2 hours of opening conference.

Detected 21 CFR Paperwork Exposures & Real 483 Citations

Zero High-Risk 21 CFR Paperwork Gaps Detected! This facility packet meets the ≥88/100 threshold for the GMPGraph Verified Readiness Badge.

Verified Compliant Controls

✓ 21 CFR 111.75(a)(1)(i) & 111.75(a)(2)(ii) — Incoming Ingredient Identity Testing & COA QualificationVERIFIED COMPLIANT IN SOP

✓ 21 CFR 111.205(a) & 21 CFR 111.260(e) — Master Manufacturing & Batch Production Records (MMR/BPR)VERIFIED COMPLIANT IN SOP

✓ 21 CFR 111.75(c) & 21 CFR 211.166 — Finished Product Testing, Stability & Expiration DatingVERIFIED COMPLIANT IN SOP

✓ 21 CFR 111.27(d), 21 CFR 117.35 & 21 CFR 211.67 — Cleaning Validation, Sanitation Logs & Pest ControlVERIFIED COMPLIANT IN SOP

✓ 21 CFR 1.502(a) & 21 CFR 117.405 — Supplier Qualification & Foreign Supplier Verification (FSVP)VERIFIED COMPLIANT IN SOP

✓ 21 CFR 111.553, FD&C Act Sec. 605 (MoCRA) & 21 CFR 820.198 — CAPA, Out-of-Specification (OOS) & Complaint InvestigationsVERIFIED COMPLIANT IN SOP

Grade Your Plant's SOPs & Batch Records Against the FDA Form 483 Corpus

1. Configure Facility Regime & SOP Input

Lone Star Nutraceuticals & Gummy Works LLC

Detected 21 CFR Paperwork Exposures & Real 483 Citations

Verified Compliant Controls

Watch This Facility for FDA Citations