Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex
Form 483 issued March 2, 2023 · Thiruporur, India
- Inspection
- Feb 20 – Mar 2, 2023
- Investigators
- Eileen A. Liu· Rajiv R. Srivastava
- Observations
- 1
- Pages
- 14
In short: On March 2, 2023, FDA issued a Form 483 with 1 observation to Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex in Thiruporur, India after an inspection that ran Feb 20 – Mar 2, 2023. The investigators were Eileen A. Liu and Rajiv R. Srivastava. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmGlobal Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex?
Eileen A. Liu and Rajiv R. Srivastava are named on this Form 483, for the inspection of Feb 20 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex inspected by FDA?
The inspection ran Feb 20 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
How do I get the full Form 483 for Global Pharma Healthcare Pvt. Ltd. A-9, SIDCO Pharmaceutical Complex?
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.