Neolpharma, Inc.
Form 483 issued June 7, 2017 · Caguas, Puerto Rico
- Inspection
- May 23 – Jun 7, 2017
- Investigators
- Libia M. Lugo· Rebeca Melendez
- Observations
- 2
- Pages
- 3
- FEI number
- 3009993897
In short: On June 7, 2017, FDA issued a Form 483 with 2 observations to Neolpharma, Inc. in Caguas, Puerto Rico (FEI 3009993897) after an inspection that ran May 23 – Jun 7, 2017. The investigators were Libia M. Lugo and Rebeca Melendez. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 2 observations.
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 objectionable microorganisms in drug products not required to be sterile are not…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmNeolpharma, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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 Neolpharma, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Neolpharma, Inc.?
Libia M. Lugo and Rebeca Melendez are named on this Form 483, for the inspection of May 23 – Jun 7, 2017. Each investigator has a profile showing what they cite most.
When was Neolpharma, Inc. inspected by FDA?
The inspection ran May 23 – Jun 7, 2017, and the Form 483 is dated June 7, 2017.
How do I get the full Form 483 for Neolpharma, 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.