VistaPharm, Inc.
Form 483 issued May 28, 2015 · Largo, Florida
- Inspection
- May 11 – May 28, 2015
- Investigator
- Jessica L. Pressley
- Observations
- 10
- Pages
- 10
- FEI number
- 1036352
In short: On May 28, 2015, FDA issued a Form 483 with 10 observations to VistaPharm, Inc. in Largo, Florida (FEI 1036352) after an inspection that ran May 11 – May 28, 2015. The investigator was Jessica L. Pressley. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 8 of 10 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, specifications…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of infonnation concerning…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VistaPharm, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected VistaPharm, Inc.?
Jessica L. Pressley is named on this Form 483, for the inspection of May 11 – May 28, 2015. Each investigator has a profile showing what they cite most.
When was VistaPharm, Inc. inspected by FDA?
The inspection ran May 11 – May 28, 2015, and the Form 483 is dated May 28, 2015.
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.