Philips Medical Systems (Cleveland) Inc.
Form 483 issued August 18, 2017 · Cleveland, Ohio
- Inspection
- Jul 17 – Aug 18, 2017
- Investigators
- Benjamin Dastoli· Christina L. Bigham· Laureen M. Geniusz
- Observations
- 9
- Pages
- 18
- FEI number
- 1525965
In short: On August 18, 2017, FDA issued a Form 483 with 9 observations to Philips Medical Systems (Cleveland) Inc. in Cleveland, Ohio (FEI 1525965) after an inspection that ran Jul 17 – Aug 18, 2017. The investigators were Benjamin Dastoli, Christina L. Bigham, Laureen M. Geniusz and Teresa K. Kastner. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 0321 CFR 820.100(a)21 CFR 820
Procedures for corrective and preventive action have…
- 04
Risk analysis is inadequate…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmPhilips Medical Systems (Cleveland) 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 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Philips Medical Systems (Cleveland) Inc.?
FDA listed 9 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Philips Medical Systems (Cleveland) Inc.?
Benjamin Dastoli, Christina L. Bigham, Laureen M. Geniusz and Teresa K. Kastner are named on this Form 483, for the inspection of Jul 17 – Aug 18, 2017. Each investigator has a profile showing what they cite most.
When was Philips Medical Systems (Cleveland) Inc. inspected by FDA?
The inspection ran Jul 17 – Aug 18, 2017, and the Form 483 is dated August 18, 2017.
How do I get the full Form 483 for Philips Medical Systems (Cleveland) Inc.?
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