Buffalo Pharmacies Inc.
Form 483 issued June 23, 2017 · East Amherst, New York
- Inspection
- Jun 23, 2017
- Investigators
- Jose O. Hernandez· Rachael Moliver
- Observations
- 6
- Pages
- 3
- FEI number
- 3010987875
In short: On June 23, 2017, FDA issued a Form 483 with 6 observations to Buffalo Pharmacies Inc. in East Amherst, New York (FEI 3010987875) after an inspection that ran Jun 23, 2017. The investigators were Jose O. Hernandez and Rachael Moliver. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Produ ct Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmBuffalo Pharmacies 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buffalo Pharmacies Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Buffalo Pharmacies Inc.?
Jose O. Hernandez and Rachael Moliver are named on this Form 483, for the inspection of Jun 23, 2017. Each investigator has a profile showing what they cite most.
When was Buffalo Pharmacies Inc. inspected by FDA?
The inspection ran Jun 23, 2017, and the Form 483 is dated June 23, 2017.
How do I get the full Form 483 for Buffalo Pharmacies 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.