Sharp Drugs, Inc.
Form 483 issued August 1, 2018 · West Hampton Beach, New York
- Inspection
- Jul 10 – Jul 13, 2018
- Investigator
- Nancy F. Scheraga
- Observations
- 6
- Pages
- 3
- FEI number
- 3014454961
In short: On August 1, 2018, FDA issued a Form 483 with 6 observations to Sharp Drugs, Inc. in West Hampton Beach, New York (FEI 3014454961) after an inspection that ran Jul 10 – Jul 13, 2018. The investigator was Nancy F. Scheraga. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 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
The ISO 5 c lassified aseptic processing area was located within a non-classified…
- 02
Disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03
Personnel engaged in aseptic…
- 04
Media fills were not performed that c losely simulate aseptic production operations incorporating, as appropriate, worst-case…
This inspection in context
Nancy F. Scheraga
9 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmSharp Drugs, Inc. history
The site's inspection history, in date order.
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 Sharp Drugs, Inc.?
FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. 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 Sharp Drugs, Inc.?
Nancy F. Scheraga is named on this Form 483, for the inspection of Jul 10 – Jul 13, 2018. Each investigator has a profile showing what they cite most.
When was Sharp Drugs, Inc. inspected by FDA?
The inspection ran Jul 10 – Jul 13, 2018, and the Form 483 is dated August 1, 2018.
How do I get the full Form 483 for Sharp Drugs, 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.