Global Calcium Pvt. Limited
Form 483 issued February 3, 2026 · Tamil Nadu, India
- Inspection
- Feb 3, 2026
- Investigators
- Alan A. Rivera· Jose E. Melendez
- Observations
- 6
- Pages
- 11
- FEI number
- 3004094136
In short: On February 3, 2026, FDA issued a Form 483 with 6 observations to Global Calcium Pvt. Limited in Tamil Nadu, Tamil Nadu (FEI 3004094136) after an inspection that ran Feb 3, 2026. The investigators were Alan A. Rivera and Jose E. Melendez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Established sampling plan and test…
- 03
Laboratory controls do not include the estabHshment of scientifically sound and appropriate test procedures designed to…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmGlobal Calcium Pvt. Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Global Calcium Pvt. Limited?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Global Calcium Pvt. Limited?
Alan A. Rivera and Jose E. Melendez are named on this Form 483, for the inspection of Feb 3, 2026. Each investigator has a profile showing what they cite most.
When was Global Calcium Pvt. Limited inspected by FDA?
The inspection ran Feb 3, 2026, and the Form 483 is dated February 3, 2026.
How do I get the full Form 483 for Global Calcium Pvt. Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.