VistaPharm, Inc.
Form 483 issued January 16, 2018 · Largo, Florida
- Investigator
- Oes C. Iy
- Observations
- 2
- Pages
- 3
- FEI number
- 1036352
In short: On January 16, 2018, FDA issued a Form 483 with 2 observations to VistaPharm, Inc. in Largo, Florida (FEI 1036352). The investigator was Oes C. Iy. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include assignment of responsibility. maintenance and cleaning schedules…
- 02
Established test procedures and laboratory control mechanisms are not followed or documented at…
This inspection in context
Oes C. Iy
1 document · 2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Florida.
The firmVistaPharm, 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VistaPharm, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected VistaPharm, Inc.?
Oes C. Iy is named on this Form 483. Each investigator has a profile showing what they cite most.
When was VistaPharm, Inc. inspected by FDA?
This Form 483 is dated January 16, 2018.
How do I get the full Form 483 for VistaPharm, 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.