Queens Express Pharmacy
Form 483 issued July 11, 2016 · Jackson Heights, New York
- Inspection
- Jun 20 – Jul 11, 2016
- Investigators
- Paul D. Teitell· Robert C. Fera
- Observations
- 5
- Pages
- 3
- FEI number
- 301231647
In short: On July 11, 2016, FDA issued a Form 483 with 5 observations to Queens Express Pharmacy in Jackson Heights, New York (FEI 301231647) after an inspection that ran Jun 20 – Jul 11, 2016. The investigators were Paul D. Teitell and Robert C. Fera. 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 4 of 5 observations.
Most cited: 21 CFR 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
Aseptic processing areas are deficient will regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Paul D. Teitell
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmQueens Express Pharmacy history
The site's inspection history, in date order.
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 Queens Express Pharmacy?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Queens Express Pharmacy?
Paul D. Teitell and Robert C. Fera are named on this Form 483, for the inspection of Jun 20 – Jul 11, 2016. Each investigator has a profile showing what they cite most.
When was Queens Express Pharmacy inspected by FDA?
The inspection ran Jun 20 – Jul 11, 2016, and the Form 483 is dated July 11, 2016.
How do I get the full Form 483 for Queens Express 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.