Neolpharma, Inc.
Form 483 issued March 10, 2026 · Caguas, Puerto Rico
- Inspection
- Mar 4 – Mar 10, 2026
- Investigator
- Angelica M. Hernandez
- Observations
- 2
- Pages
- 6
- FEI number
- 3009993897
In short: On March 10, 2026, FDA issued a Form 483 with 2 observations to Neolpharma, Inc. in Caguas, Puerto Rico (FEI 3009993897) after an inspection that ran Mar 4 – Mar 10, 2026. The investigator was Angelica M. Hernandez. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.56(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Neolpharma, Inc.?
Angelica M. Hernandez is named on this Form 483, for the inspection of Mar 4 – Mar 10, 2026. Each investigator has a profile showing what they cite most.
When was Neolpharma, Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 10, 2026, and the Form 483 is dated March 10, 2026.
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.