Metro Drugs 3rd Avenue Corp.
Form 483 issued April 5, 2019 · New York, New York
- Inspection
- Mar 14 – Apr 5, 2019
- Investigator
- Rachael Moliver
- Observations
- 5
- Pages
- 3
- FEI number
- 3011795133
In short: On April 5, 2019, FDA issued a Form 483 with 5 observations to Metro Drugs 3rd Avenue Corp. in New York, New York (FEI 3011795133) after an inspection that ran Mar 14 – Apr 5, 2019. The investigator was Rachael Moliver. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area aseptic processing…
- 02
Your firm released drug product in which the strength differs from, or its purity or quality…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
ISO-5 classified areas were not…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmMetro Drugs 3rd Avenue Corp. 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 Metro Drugs 3rd Avenue Corp.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Metro Drugs 3rd Avenue Corp.?
Rachael Moliver is named on this Form 483, for the inspection of Mar 14 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Metro Drugs 3rd Avenue Corp. inspected by FDA?
The inspection ran Mar 14 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Metro Drugs 3rd Avenue Corp.?
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.