Medisca Inc.
Form 483 issued February 27, 2014 · Plattsburgh, New York
- Inspection
- Feb 17 – Feb 27, 2014
- Investigator
- Chad N. Thompson
- Observations
- 3
- Pages
- 2
- FEI number
- 1000120311
In short: On February 27, 2014, FDA issued a Form 483 with 3 observations to Medisca Inc. in Plattsburgh, New York (FEI 1000120311) after an inspection that ran Feb 17 – Feb 27, 2014. The investigator was Chad N. Thompson. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.84 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Examination and testing of incoming…
- 02
Investigations of customer complaints are inadequate in that they did not extend to other batches of…
- 03
Authentic Certificates of Analysis were not issued for…
This inspection in context
Chad N. Thompson
7 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmMedisca Inc. history
All 3 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 Medisca Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and quality system. 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 Medisca Inc.?
Chad N. Thompson is named on this Form 483, for the inspection of Feb 17 – Feb 27, 2014. Each investigator has a profile showing what they cite most.
When was Medisca Inc. inspected by FDA?
The inspection ran Feb 17 – Feb 27, 2014, and the Form 483 is dated February 27, 2014.
How do I get the full Form 483 for Medisca 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.