Philips Medical Systems (Cleveland) Inc.
FDA inspection history in Cleveland, Ohio, 2011 to 2017
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Form 483
- Warning letter
2011: two warning letters; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011Two warning letters, at Cleveland, Ohio.
- 2017One Form 483, at Cleveland, Ohio.
Cited most
Across all Philips Medical Systems (Cleveland) observations on file
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.30(g)Design controls2
- 21 CFR 8031
- 21 CFR 8201
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
The complete Philips Medical Systems (Cleveland) file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cleveland, Ohio
Two warning letters and one Form 483 · 2011 to 2017 · 9 observations
Latest: Form 483, Aug 18, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-08-18 | 483 Form 483 | Cleveland, Ohio | 9 | $99 |
| 2011-06-07 | Warning letter Warning letter | Cleveland, Ohio | — | $99 |
| 2011-06-07 | Warning letter Warning letter | Cleveland, Ohio | — | $99 |
Investigators on these documents
Benjamin Dastoli (1)Christina L. Bigham (1)Laureen M. Geniusz (1)Teresa K. Kastner (1)
FEI number 1525965 · most recent document Aug 18, 2017
About Philips Medical Systems (Cleveland) Inc.
How many FDA Form 483s has Philips Medical Systems (Cleveland) Inc. received?
FDA Intel has 1 Form 483 on file for Philips Medical Systems (Cleveland) Inc.; the most recent is dated Aug 18, 2017.
When was Philips Medical Systems (Cleveland) Inc. last inspected by FDA?
The most recent FDA inspection document on file for Philips Medical Systems (Cleveland) Inc. is a Form 483 dated Aug 18, 2017, for the site in Cleveland, Ohio.
What did FDA cite at Philips Medical Systems (Cleveland) Inc.?
The regulations cited most in the observations on file for Philips Medical Systems (Cleveland) Inc. are 21 CFR 820.198(a) (Complaint files), 2 times; 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 803, 1 time.
Has Philips Medical Systems (Cleveland) Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Philips Medical Systems (Cleveland) Inc.; the most recent is dated Jun 7, 2011.