Apex Pharmaceuticals, Inc.
Form 483 issued April 18, 2019 · South Plainfield, New Jersey
- Inspection
- Apr 3 – Apr 18, 2019
- Investigator
- Unnee Ranjan
- Observations
- 6
- Pages
- 3
- FEI number
- 3006719767
In short: On April 18, 2019, FDA issued a Form 483 with 6 observations to Apex Pharmaceuticals, Inc. in South Plainfield, New Jersey (FEI 3006719767) after an inspection that ran Apr 3 – Apr 18, 2019. The investigator was Unnee Ranjan. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
5 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (5×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Detergent residual studies were not performed for the detergents (b) (4) which are used for the…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmApex Pharmaceuticals, Inc. history
The site's inspection history, in date order.
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 Apex Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Apex Pharmaceuticals, Inc.?
Unnee Ranjan is named on this Form 483, for the inspection of Apr 3 – Apr 18, 2019. Each investigator has a profile showing what they cite most.
When was Apex Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Apr 3 – Apr 18, 2019, and the Form 483 is dated April 18, 2019.
How do I get the full Form 483 for Apex Pharmaceuticals, 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.