Form FDA 483 · Issued 2026-01-27
Neeyaan LLC — FDA Form 483 Analysis
FEI: 3024366553 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Neeyaan LLC (FEI 3024366553) on 2026-01-27 following an inspection of its manufacturer operations in New Jersey. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.188(b)(8)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Labeling Control Records and Label Copies
Inspector Observation Language: "The batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of labeling. Specifically, observed during inspection of Neeyaan LLC on 2026-01-27."
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 #2 · 21 CFR 211.196
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Distribution Record Requirements
Inspector Observation Language: "Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, observed during inspection of Neeyaan LLC on 2026-01-27."
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 #3 · 21 CFR 211.48(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Plumbing System Defects
Inspector Observation Language: "The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, observed during inspection of Neeyaan LLC on 2026-01-27."
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.