Neolpharma, Inc.
Form 483 issued February 5, 2019 · Caguas, Puerto Rico
- Inspection
- Jan 24 – Feb 5, 2019
- Investigator
- Ariel Cruz Figueroa
- Observations
- 1
- Pages
- 3
- FEI number
- 3009993897
In short: On February 5, 2019, FDA issued a Form 483 with 1 observation to Neolpharma, Inc. in Caguas, Puerto Rico (FEI 3009993897) after an inspection that ran Jan 24 – Feb 5, 2019. The investigator was Ariel Cruz Figueroa. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) 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(a)
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 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Neolpharma, Inc.?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Jan 24 – Feb 5, 2019. Each investigator has a profile showing what they cite most.
When was Neolpharma, Inc. inspected by FDA?
The inspection ran Jan 24 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
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.