Neolpharma, Inc.
Form 483 issued April 1, 2022 · Caguas, Puerto Rico
- Inspection
- Mar 22 – Apr 1, 2022
- Investigators
- Alan A. Rivera· Angelica M. Hernandez· Marian E. Ramirez
- Observations
- 1
- Pages
- 8
- FEI number
- 3009993897
In short: On April 1, 2022, FDA issued a Form 483 with 1 observation to Neolpharma, Inc. in Caguas, Puerto Rico (FEI 3009993897) after an inspection that ran Mar 22 – Apr 1, 2022. The investigators were Alan A. Rivera, Angelica M. Hernandez and Marian E. Ramirez. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production and. process…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neolpharma, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Neolpharma, Inc.?
Alan A. Rivera, Angelica M. Hernandez and Marian E. Ramirez are named on this Form 483, for the inspection of Mar 22 – Apr 1, 2022. Each investigator has a profile showing what they cite most.
When was Neolpharma, Inc. inspected by FDA?
The inspection ran Mar 22 – Apr 1, 2022, and the Form 483 is dated April 1, 2022.
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.