GPC Medical Limited
Form 483 issued October 21, 2019
- Investigator
- Stephen D. Eich
- Observations
- 5
- Pages
- 2
- FEI number
- 3006513362
In short: On October 21, 2019, FDA issued a Form 483 with 5 observations to GPC Medical Limited (FEI 3006513362). The investigator was Stephen D. Eich. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
4 of 5 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process Control Procedures that describe any process controls necessary to ensure conformance to the specifications have…
- 02
Procedures for acceptance of in-process product have…
- 03
Procedures for Corrective and Preventive Action have…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has…
This inspection in context
Stephen D. Eich
6 documents · 2019–2025
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Illinois.
The firmGPC Medical Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GPC Medical Limited?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected GPC Medical Limited?
Stephen D. Eich is named on this Form 483. Each investigator has a profile showing what they cite most.
When was GPC Medical Limited inspected by FDA?
This Form 483 is dated October 21, 2019.
How do I get the full Form 483 for GPC Medical Limited?
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.