Infupharma LLCd.b.a. President Pharmacy
Form 483 issued February 5, 2015 · Hollywood, Florida
- Inspection
- Feb 3 – Feb 5, 2015
- Investigator
- Ileana Barreto-Pettit
- Observations
- 2
- Pages
- 2
- FEI number
- 3008058540
In short: On February 5, 2015, FDA issued a Form 483 with 2 observations to Infupharma LLCd.b.a. President Pharmacy in Hollywood, Florida (FEI 3008058540) after an inspection that ran Feb 3 – Feb 5, 2015. The investigator was Ileana Barreto-Pettit. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×) · 211.165(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmInfupharma LLCd.b.a. President Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infupharma LLCd.b.a. President Pharmacy?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. 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 Infupharma LLCd.b.a. President Pharmacy?
Ileana Barreto-Pettit is named on this Form 483, for the inspection of Feb 3 – Feb 5, 2015. Each investigator has a profile showing what they cite most.
When was Infupharma LLCd.b.a. President Pharmacy inspected by FDA?
The inspection ran Feb 3 – Feb 5, 2015, and the Form 483 is dated February 5, 2015.
How do I get the full Form 483 for Infupharma LLCd.b.a. President Pharmacy?
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.