Veltek Associates, Inc.
Form 483 issued November 14, 2018 · Malvern, Pennsylvania
- Inspection
- Nov 6 – Nov 14, 2018
- Investigator
- Craig D. Zagata
- Observations
- 4
- Pages
- 2
- FEI number
- 3001342291
In short: On November 14, 2018, FDA issued a Form 483 with 4 observations to Veltek Associates, Inc. in Malvern, Pennsylvania (FEI 3001342291) after an inspection that ran Nov 6 – Nov 14, 2018. The investigator was Craig D. Zagata. Most observations concern facilities & equipment and quality system.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written procedures are not established and followed for evaluations done at least annually and including provisions…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmVeltek Associates, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Veltek Associates, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Veltek Associates, Inc.?
Craig D. Zagata is named on this Form 483, for the inspection of Nov 6 – Nov 14, 2018. Each investigator has a profile showing what they cite most.
When was Veltek Associates, Inc. inspected by FDA?
The inspection ran Nov 6 – Nov 14, 2018, and the Form 483 is dated November 14, 2018.
How do I get the full Form 483 for Veltek Associates, 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.