Neolpharma, Inc.
Form 483 issued June 18, 2015 · Caguas, Puerto Rico
- Inspection
- Jun 2 – Jun 18, 2015
- Investigators
- Brian J. Ryan· Libia M. Lugo
- Observations
- 7
- Pages
- 10
- FEI number
- 3009993897
In short: On June 18, 2015, FDA issued a Form 483 with 7 observations to Neolpharma, Inc. in Caguas, Puerto Rico (FEI 3009993897) after an inspection that ran Jun 2 – Jun 18, 2015. The investigators were Brian J. Ryan and Libia M. Lugo. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.110 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Brian J. Ryan
2 documents · 2015
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in New York.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neolpharma, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Neolpharma, Inc.?
Brian J. Ryan and Libia M. Lugo are named on this Form 483, for the inspection of Jun 2 – Jun 18, 2015. Each investigator has a profile showing what they cite most.
When was Neolpharma, Inc. inspected by FDA?
The inspection ran Jun 2 – Jun 18, 2015, and the Form 483 is dated June 18, 2015.
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.