YFS Pharma, inc
Form 483 issued May 21, 2021 · Buffalo, New York
- Inspection
- May 17 – May 21, 2021
- Investigator
- Matthew D. Schnittker
- Observations
- 9
- Pages
- 6
- FEI number
- 3014268952
In short: On May 21, 2021, FDA issued a Form 483 with 9 observations to YFS Pharma, inc in Buffalo, New York (FEI 3014268952) after an inspection that ran May 17 – May 21, 2021. The investigator was Matthew D. Schnittker. Most observations concern design controls and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
What FDA observed
Preview: the opening words of each observation- 01
Quality audits were not performed to determine whether the quality system activities and results comply…
- 02
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…
- 03
Design input requirements were…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmYFS Pharma, inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at YFS Pharma, inc?
FDA listed 9 observations on this Form 483, mostly about design controls, management controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected YFS Pharma, inc?
Matthew D. Schnittker is named on this Form 483, for the inspection of May 17 – May 21, 2021. Each investigator has a profile showing what they cite most.
When was YFS Pharma, inc inspected by FDA?
The inspection ran May 17 – May 21, 2021, and the Form 483 is dated May 21, 2021.
How do I get the full Form 483 for YFS Pharma, inc?
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.