Pacifico National Inc. dba Amex Pharmacy
Form 483 issued May 31, 2019 · Melbourne, Florida
- Inspection
- Apr 15 – May 31, 2019
- Investigators
- Brandon C. Heitmeier· June P. Page· Philip F. Istafanos
- Observations
- 14
- Pages
- 14
- FEI number
- 3012034698
In short: On May 31, 2019, FDA issued a Form 483 with 14 observations to Pacifico National Inc. dba Amex Pharmacy in Melbourne, Florida (FEI 3012034698) after an inspection that ran Apr 15 – May 31, 2019. The investigators were Brandon C. Heitmeier, June P. Page, Philip F. Istafanos and Susan T. Hadman. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmPacifico National Inc. dba Amex Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pacifico National Inc. dba Amex Pharmacy?
FDA listed 14 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pacifico National Inc. dba Amex Pharmacy?
Brandon C. Heitmeier, June P. Page, Philip F. Istafanos and Susan T. Hadman are named on this Form 483, for the inspection of Apr 15 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Pacifico National Inc. dba Amex Pharmacy inspected by FDA?
The inspection ran Apr 15 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Pacifico National Inc. dba Amex 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.