Form FDA 483 · Issued 2026-02-12
Enemeez LLC — FDA Form 483 Analysis
FEI: 3005641023 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Enemeez LLC (FEI 3005641023) on 2026-02-12 following an inspection of its manufacturer operations in Arizona. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 212.20(c)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Specifications and processes
Inspector Observation Language: "You did not approve or reject, before implementation, [any initial] [any proposed changes to existing] [specifications] [methods] [processes or procedures] to ensure that they maintain the identity, strength, quality, and purity of a PET drug. Specifically, observed during inspection of Enemeez LLC on 2026-02-12."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 212.70(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Conform to specs prior to release
Inspector Observation Language: "You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release. Specifically, observed during inspection of Enemeez LLC on 2026-02-12."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #3 · 21 CFR 314.80(c)(2)(ii)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Late submission of an ICSR
Inspector Observation Language: "You failed to submit an ICSR for the reporting period [within 30 days of the close of the quarter] [within 60 days of the anniversary date of the approval of the application]. Specifically, observed during inspection of Enemeez LLC on 2026-02-12."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #4 · 21 CFR 211.28(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Clothing appropriate for duties performed
Inspector Observation Language: "Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, observed during inspection of Enemeez LLC on 2026-02-12."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.