Pacifico National Inc. dba Amex Pharmacy
Form 483 issued January 21, 2016 · Melbourne, Florida
- Inspection
- Jan 12 – Jan 21, 2016
- Investigators
- Ileana Barreto-Pettit· Jessica L. Pressley
- Observations
- 11
- Pages
- 12
- FEI number
- 3012034698
In short: On January 21, 2016, FDA issued a Form 483 with 11 observations to Pacifico National Inc. dba Amex Pharmacy in Melbourne, Florida (FEI 3012034698) after an inspection that ran Jan 12 – Jan 21, 2016. The investigators were Ileana Barreto-Pettit and Jessica L. Pressley. Most observations concern production and quality system; 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 211.42 (2×) · 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Your firm failed to establish and follow an Out of Specification (OOS) Procedure. As a result…
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 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 211.42
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 11 observations on this Form 483, mostly about production, quality system 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?
Ileana Barreto-Pettit and Jessica L. Pressley are named on this Form 483, for the inspection of Jan 12 – Jan 21, 2016. Each investigator has a profile showing what they cite most.
When was Pacifico National Inc. dba Amex Pharmacy inspected by FDA?
The inspection ran Jan 12 – Jan 21, 2016, and the Form 483 is dated January 21, 2016.
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.