Life Science Pharmacy Inc.
Form 483 issued November 20, 2019 · Harriman, New York
- Inspection
- Nov 6 – Nov 20, 2019
- Investigator
- Rachael Moliver
- Observations
- 5
- Pages
- 4
- FEI number
- 3006997792
In short: On November 20, 2019, FDA issued a Form 483 with 5 observations to Life Science Pharmacy Inc. in Harriman, New York (FEI 3006997792) after an inspection that ran Nov 6 – Nov 20, 2019. The investigator was 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 4 of 5 observations.
Most cited: 21 CFR 211.42 (2×) · 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
Non-phaimaceutical grade components are used in the formulation of…
- 02
ISO-5 classified ai·eas were not…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
Pressure differentials between areas with different air classifications were not monitored prior or…
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 firmLife Science Pharmacy Inc. history
All 4 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 Life Science Pharmacy Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. 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 Life Science Pharmacy Inc.?
Rachael Moliver is named on this Form 483, for the inspection of Nov 6 – Nov 20, 2019. Each investigator has a profile showing what they cite most.
When was Life Science Pharmacy Inc. inspected by FDA?
The inspection ran Nov 6 – Nov 20, 2019, and the Form 483 is dated November 20, 2019.
How do I get the full Form 483 for Life Science Pharmacy 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.