Galephar Pharmaceutical Research Inc.
Form 483 issued June 9, 2021 · Juncos, Puerto Rico
- Inspection
- Jun 1 – Jun 9, 2021
- Investigators
- Ariel Cruz Figueroa· Raquel Gonzalez Rivera
- Observations
- 2
- Pages
- 4
- FEI number
- 3003068480
In short: On June 9, 2021, FDA issued a Form 483 with 2 observations to Galephar Pharmaceutical Research Inc. in Juncos, Puerto Rico (FEI 3003068480) after an inspection that ran Jun 1 – Jun 9, 2021. The investigators were Ariel Cruz Figueroa and Raquel Gonzalez Rivera. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system 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
The accuracy, sensitivity, specificity, reproducibility oftest methods has not…
- 02
The responsibilities and procedures applicable to the quality control unit are…
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 firmGalephar Pharmaceutical Research Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Galephar Pharmaceutical Research Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Galephar Pharmaceutical Research Inc.?
Ariel Cruz Figueroa and Raquel Gonzalez Rivera are named on this Form 483, for the inspection of Jun 1 – Jun 9, 2021. Each investigator has a profile showing what they cite most.
When was Galephar Pharmaceutical Research Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 9, 2021, and the Form 483 is dated June 9, 2021.
How do I get the full Form 483 for Galephar Pharmaceutical Research 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.