Form FDA 483 · Issued 2025-09-18
Immacule Lifesciences Private Limited — FDA Form 483 Analysis
FEI: 3014210753 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Immacule Lifesciences Private Limited (FEI 3014210753) on 2025-09-18 following an inspection of its sterile drug manufacturer operations in India. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 2 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Written calibration procedures
Inspector Observation Language: "Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met]. Specifically, observed during inspection of Immacule Lifesciences Private Limited on 2025-09-18."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 211.170(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Reserve sample quantity - active ingredients only
Inspector Observation Language: "The reserve sample of active ingredient does not consist of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications. Specifically, observed during inspection of Immacule Lifesciences Private Limited on 2025-09-18."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.