Form FDA 483 · Issued 2026-02-05
Life Recovery Systems HD, LLC — FDA Form 483 Analysis
FEI: 3006059109 · Sector: Medical Devices (Medical Device Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Life Recovery Systems HD, LLC (FEI 3006059109) on 2026-02-05 following an inspection of its medical device manufacturer operations in New Jersey. The report documents 2 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 820.75(c)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Documentation - review in response to changes or deviations
Inspector Observation Language: "There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations. Specifically, observed during inspection of Life Recovery Systems HD, LLC on 2026-02-05."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #2 · 21 CFR 820.40(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Document review procedures, designated individual
Inspector Observation Language: "The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, observed during inspection of Life Recovery Systems HD, LLC on 2026-02-05."
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.