MasterPharm LLC
Form 483 issued June 15, 2020 · South Richmond Hill, New York
- Inspection
- Jun 1 – Jun 15, 2020
- Investigator
- Guerlain Ulysse
- Observations
- 7
- Pages
- 6
- FEI number
- 3005734706
In short: On June 15, 2020, FDA issued a Form 483 with 7 observations to MasterPharm LLC in South Richmond Hill, New York (FEI 3005734706) after an inspection that ran Jun 1 – Jun 15, 2020. The investigator was Guerlain Ulysse. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 7 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (4×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
The ISO classified aseptic processing areas have difficult to clean, particle-generating and visibly…
- 03
Non-microbial contamination was observed…
- 04
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 MasterPharm LLC?
Guerlain Ulysse is named on this Form 483, for the inspection of Jun 1 – Jun 15, 2020. Each investigator has a profile showing what they cite most.
When was MasterPharm LLC inspected by FDA?
The inspection ran Jun 1 – Jun 15, 2020, and the Form 483 is dated June 15, 2020.
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.