Pfizer Healthcare India Private Limited
Form 483 issued October 18, 2022 · Visakhapatnam, India
- Inspection
- Oct 10 – Oct 18, 2022
- Investigator
- Junho Pak
- Observations
- 1
- Pages
- 3
- FEI number
- 3008316085
In short: On October 18, 2022, FDA issued a Form 483 with 1 observation to Pfizer Healthcare India Private Limited in Visakhapatnam, Andhra Pradesh (FEI 3008316085) after an inspection that ran Oct 10 – Oct 18, 2022. The investigator was Junho Pak. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPfizer Healthcare India Private 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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Healthcare India Private Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Pfizer Healthcare India Private Limited?
Junho Pak is named on this Form 483, for the inspection of Oct 10 – Oct 18, 2022. Each investigator has a profile showing what they cite most.
When was Pfizer Healthcare India Private Limited inspected by FDA?
The inspection ran Oct 10 – Oct 18, 2022, and the Form 483 is dated October 18, 2022.
How do I get the full Form 483 for Pfizer Healthcare India Private 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.