MasterPharm LLC
Form 483 issued May 6, 2015 · Richmond Hill, New York
- Inspection
- May 6, 2015
- Investigator
- James A. Liubicich
- Observations
- 6
- Pages
- 4
- FEI number
- 3005734706
In short: On May 6, 2015, FDA issued a Form 483 with 6 observations to MasterPharm LLC in Richmond Hill, New York (FEI 3005734706) after an inspection that ran May 6, 2015. The investigator was James A. Liubicich. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (4×)
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 regarding systems for maintaining any equipment used to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmMasterPharm LLC history
All 5 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 MasterPharm LLC?
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 MasterPharm LLC?
James A. Liubicich is named on this Form 483, for the inspection of May 6, 2015. Each investigator has a profile showing what they cite most.
When was MasterPharm LLC inspected by FDA?
The inspection ran May 6, 2015, and the Form 483 is dated May 6, 2015.
How do I get the full Form 483 for MasterPharm LLC?
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.