Form 483 · FEI 3004051616
Form 483 issued October 28, 2019 · Pashamylaram, India
- Inspection
- Oct 21 – Oct 28, 2019
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 3
- FEI number
- 3004051616
In short: On October 28, 2019, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Pashamylaram, Patancheru (FEI 3004051616) after an inspection that ran Oct 21 – Oct 28, 2019. The investigator was Michael A. Charles. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not always include the establishment of scientilically sound and appropriate procedures designed to…
- 02
Equipment for adequate control over micro-organisms is not always provided when appropriate for the manufacture, processing…
- 03
The aseptic processing area is deficient regarding the system…
- 04
Process validation does not always include inclusion and establishment of all process parameters that should be…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmSite history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Michael A. Charles is named on this Form 483, for the inspection of Oct 21 – Oct 28, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Oct 21 – Oct 28, 2019, and the Form 483 is dated October 28, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.