Reading Hospital and Medical Center
Form 483 issued December 16, 2015 · West Reading, Pennsylvania
- Inspection
- Dec 8 – Dec 16, 2015
- Investigator
- Edward Medon
- Observations
- 5
- Pages
- 4
- FEI number
- 2571104
In short: On December 16, 2015, FDA issued a Form 483 with 5 observations to Reading Hospital and Medical Center in West Reading, Pennsylvania (FEI 2571104) after an inspection that ran Dec 8 – Dec 16, 2015. The investigator was Edward Medon. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?).
At a glance
4 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
The user facility did not submit FDA Form 3500A or electronic equivalent to within ten working…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the within 10…
- 04
The written MDR procedure does not include documentation and recordkeeping requirements for all information that was…
- 05
MDR event files have not…
This inspection in context
Edward Medon
1 document · 2015
Cites 803.30(a)(1) (if i am a user facility, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmReading Hospital and Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.30(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reading Hospital and Medical Center?
FDA listed 5 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Reading Hospital and Medical Center?
Edward Medon is named on this Form 483, for the inspection of Dec 8 – Dec 16, 2015. Each investigator has a profile showing what they cite most.
When was Reading Hospital and Medical Center inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2015, and the Form 483 is dated December 16, 2015.
How do I get the full Form 483 for Reading Hospital and Medical Center?
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.