Global Calcium Pvt. Limited
FDA inspection history across 3 sites, 2024 to 2026
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2024: one Form 483; 2025: one warning letter; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–26Two Form 483s and one warning letter, at Hosur, India; Bengaluru, India and Tamil Nadu, India.
- 2026The longest 483 on file: 6 observations over 11 pages at Tamil Nadu, India.
Cited most
Across all Global Calcium Pvt. Limited observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Global Calcium Pvt. Limited file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Tamil Nadu, India
One Form 483 · 2026 · 6 observations
Latest: Form 483, Feb 3, 2026 →Bengaluru, India
One warning letter · 2025
Latest: Warning letter, Jan 16, 2025 →Hosur, India
One Form 483 · 2024 · 1 observation
Latest: Form 483, Aug 2, 2024 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-03 | 483 Form 483 | Tamil Nadu, India | 6 | $99 |
| 2025-01-16 | Warning letter Warning letter | Bengaluru, India | — | $99 |
| 2024-08-02 | 483 Form 483 | Hosur, India | 1 | $99 |
| Undated | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
Alan A. Rivera (1)Jose E. Melendez (1)Justin A. Boyd (1)Teresa I. Navas (1)
FEI number 3004094136 · most recent document Feb 3, 2026
About Global Calcium Pvt. Limited
How many FDA Form 483s has Global Calcium Pvt. Limited received?
FDA Intel has 2 Form 483s on file for Global Calcium Pvt. Limited; the most recent is dated Feb 3, 2026.
When was Global Calcium Pvt. Limited last inspected by FDA?
The most recent FDA inspection document on file for Global Calcium Pvt. Limited is a Form 483 dated Feb 3, 2026, for the site in Tamil Nadu, India.
What did FDA cite at Global Calcium Pvt. Limited?
The regulations cited most in the observations on file for Global Calcium Pvt. Limited are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.
Has Global Calcium Pvt. Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Global Calcium Pvt. Limited; the most recent is dated Jan 16, 2025.