Form FDA 483 · Issued 2026-02-03
Global Calcium Private Limited — FDA Form 483 Analysis
FEI: 3004094136 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Active Pharmaceutical Ingredient Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Global Calcium Private Limited (FEI 3004094136) on 2026-02-03 following an inspection of its active pharmaceutical ingredient manufacturer operations in India. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.84(c)(4)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Top/Middle/Bottom container sampling
Inspector Observation Language: "Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. Specifically, observed during inspection of Global Calcium Private Limited on 2026-02-03."
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 211.166(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Accelerated stability studies
Inspector Observation Language: "Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies. Specifically, observed during inspection of Global Calcium Private Limited on 2026-02-03."
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 #3 · 21 CFR 211.188(b)(7)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Actual Yield and Theoretical Yield
Inspector Observation Language: "The batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical yield]. Specifically, observed during inspection of Global Calcium Private Limited on 2026-02-03."
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 #4 · 21 CFR 211.194(d)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Laboratory equipment calibration records
Inspector Observation Language: "Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, observed during inspection of Global Calcium Private Limited on 2026-02-03."
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.