Nicholas C. Mendiola
FDA investigator
Appears on 4 documents from 2015 to 2018, mostly at sites in New York. Most often cites what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? (21 CFR 803.17).
- 4
- Documents on file
- 1.8
- Observations per 483
- 2015
- First seen
- 2018
- Most recent
What they cite most
From 7 observations- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.30Design controls1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90(a)Nonconforming product1
Activity by year
2015: 3, 2018: 1
Where
New York 4
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-08-15 | 483 Carestream Health, IncAug 15, 2018 · Rochester, New York | Rochester, New York | 3 | |
| 2015-05-15 | 483 Ortho Clinicial Diagnostics, IncMay 15, 2015 · Rochester, New York | Rochester, New York | 1 | |
| 2015-05-04 | 483 New Product Development Inc.(dba ForestMay 4, 2015 · East Syracuse, New York | East Syracuse, New York | 2 | |
| 2015-02-09 | 483 Rochester General HospitalFeb 9, 2015 · Rochester, New York | Rochester, New York | 1 |
About this profile
What does Nicholas C. Mendiola inspect?
Nicholas C. Mendiola appears on 4 documents on file covering 3 sites, mostly in New York.
What do they cite most often?
21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), followed by 21 CFR 820.100(b) and 21 CFR 820.198.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Nicholas C. Mendiola is dated Aug 15, 2018.