Global Calcium Pvt. Limited
Form 483 issued August 2, 2024 · Hosur, India
- Inspection
- Jul 29 – Aug 2, 2024
- Investigators
- Justin A. Boyd· Teresa I. Navas
- Observations
- 1
- Pages
- 7
- FEI number
- 3004094136
In short: On August 2, 2024, FDA issued a Form 483 with 1 observation to Global Calcium Pvt. Limited in Hosur, India (FEI 3004094136) after an inspection that ran Jul 29 – Aug 2, 2024. The investigators were Justin A. Boyd and Teresa I. Navas. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production records do not contain complete information relating to the production and…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Global Calcium Pvt. Limited?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Global Calcium Pvt. Limited?
Justin A. Boyd and Teresa I. Navas are named on this Form 483, for the inspection of Jul 29 – Aug 2, 2024. Each investigator has a profile showing what they cite most.
When was Global Calcium Pvt. Limited inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2024, and the Form 483 is dated August 2, 2024.
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.