Curia Global, Inc.
Form 483 issued January 15, 2019 · Albany, New York
- Inspection
- Jan 9 – Jan 15, 2019
- Investigator
- Rajiv R. Srivastava
- Observations
- 4
- Pages
- 2
- FEI number
- 1000220178
In short: On January 15, 2019, FDA issued a Form 483 with 4 observations to Curia Global, Inc. in Albany, New York (FEI 1000220178) after an inspection that ran Jan 9 – Jan 15, 2019. The investigator was Rajiv R. Srivastava. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your cleaning procedures are deficient in that they fail to prevent contamination or carry-over of a…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Your procedures for Inventory and Warehouse system are deficient such that your separate or defined areas…
- 04
Batch Production and Control Records are deficient such that your procedure, ALB-SOP-0325 Preparation, Approval, Issuance, and…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCuria Global, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia Global, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Curia Global, Inc.?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Jan 9 – Jan 15, 2019. Each investigator has a profile showing what they cite most.
When was Curia Global, Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 15, 2019, and the Form 483 is dated January 15, 2019.
How do I get the full Form 483 for Curia Global, Inc.?
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.