MasterPharm LLC
Form 483 issued January 30, 2017 · Richmond Hill, New York
- Inspection
- Jan 17 – Jan 30, 2017
- Investigator
- Alice S. Tsao
- Observations
- 2
- Pages
- 1
- FEI number
- 3005734706
In short: On January 30, 2017, FDA issued a Form 483 with 2 observations to MasterPharm LLC in Richmond Hill, New York (FEI 3005734706) after an inspection that ran Jan 17 – Jan 30, 2017. The investigator was Alice S. Tsao. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.94 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Fai lure to conduct adequate…
- 02
Fai lure to depyrogenate stoppers used in the production…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MasterPharm LLC?
FDA listed 2 observations on this Form 483, mostly about production and materials. 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 MasterPharm LLC?
Alice S. Tsao is named on this Form 483, for the inspection of Jan 17 – Jan 30, 2017. Each investigator has a profile showing what they cite most.
When was MasterPharm LLC inspected by FDA?
The inspection ran Jan 17 – Jan 30, 2017, and the Form 483 is dated January 30, 2017.
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.