Pharmaceutics International Inc
Form 483 issued July 10, 2020 · Hunt Valley, Maryland
- Inspection
- Jul 6 – Jul 10, 2020
- Investigators
- Edmund F. Mrak· Robert J. Martin
- Observations
- 1
- Pages
- 2
- FEI number
- 1000513101
In short: On July 10, 2020, FDA issued a Form 483 with 1 observation to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Jul 6 – Jul 10, 2020. The investigators were Edmund F. Mrak and Robert J. Martin. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharmaceutics International Inc history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
Edmund F. Mrak and Robert J. Martin are named on this Form 483, for the inspection of Jul 6 – Jul 10, 2020. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Jul 6 – Jul 10, 2020, and the Form 483 is dated July 10, 2020.
How do I get the full Form 483 for Pharmaceutics International 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.