VistaPharm, Inc.
Form 483 issued September 2, 2022 · Largo, Florida
- Inspection
- Aug 25 – Sep 2, 2022
- Investigators
- Damaris Y. Hernandez· Nicole E. Knowlton· Steven A. Brettler
- Observations
- 3
- Pages
- 4
- FEI number
- 1036352
In short: On September 2, 2022, FDA issued a Form 483 with 3 observations to VistaPharm, Inc. in Largo, Florida (FEI 1036352) after an inspection that ran Aug 25 – Sep 2, 2022. The investigators were Damaris Y. Hernandez, Nicole E. Knowlton and Steven A. Brettler. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VistaPharm, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected VistaPharm, Inc.?
Damaris Y. Hernandez, Nicole E. Knowlton and Steven A. Brettler are named on this Form 483, for the inspection of Aug 25 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was VistaPharm, Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
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.