Pharmaneek Inc.
Form 483 issued April 8, 2026 · Ind ianapolis, Indiana
- Inspection
- Mar 30 – Apr 8, 2026
- Investigator
- Janet A. Rajan
- Observations
- 3
- Pages
- 3
- FEI number
- 3014484244
In short: On April 8, 2026, FDA issued a Form 483 with 3 observations to Pharmaneek Inc. in Ind ianapolis, Indiana (FEI 3014484244) after an inspection that ran Mar 30 – Apr 8, 2026. The investigator was Janet A. Rajan. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Hazardous chugs were produced without providing adequate containment segregation, and/or cleaning of work smfaces, utensils, and/or…
- 02
Yom fmn failed to confirm that the quality of water was suitable for its intended use…
- 03
Your fac.ility is not maintained in a good state of repair, creating insanitaiy conditions whereby drng…
This inspection in context
Janet A. Rajan
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmPharmaneek Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaneek Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Pharmaneek Inc.?
Janet A. Rajan is named on this Form 483, for the inspection of Mar 30 – Apr 8, 2026. Each investigator has a profile showing what they cite most.
When was Pharmaneek Inc. inspected by FDA?
The inspection ran Mar 30 – Apr 8, 2026, and the Form 483 is dated April 8, 2026.
How do I get the full Form 483 for Pharmaneek 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.