KVK-TECH, INC.
Form 483 issued April 16, 2019 · Newtown, Pennsylvania
- Inspection
- Apr 9 – Apr 16, 2019
- Investigators
- Michael R. Klapal· Nicholas Violand· Patric C. Klotzbuecher
- Observations
- 7
- Pages
- 11
- FEI number
- 3005117563
In short: On April 16, 2019, FDA issued a Form 483 with 7 observations to KVK-TECH, INC. in Newtown, Pennsylvania (FEI 3005117563) after an inspection that ran Apr 9 – Apr 16, 2019. The investigators were Michael R. Klapal, Nicholas Violand, Patric C. Klotzbuecher and Yvesna Blaise. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 6 of 7 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The written record did not include the reason an investigation was found not to be necessary…
- 04
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Michael R. Klapal
5 documents · 2013–2019
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New Jersey.
The firmKVK-TECH, INC. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KVK-TECH, INC.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected KVK-TECH, INC.?
Michael R. Klapal, Nicholas Violand, Patric C. Klotzbuecher and Yvesna Blaise are named on this Form 483, for the inspection of Apr 9 – Apr 16, 2019. Each investigator has a profile showing what they cite most.
When was KVK-TECH, INC. inspected by FDA?
The inspection ran Apr 9 – Apr 16, 2019, and the Form 483 is dated April 16, 2019.
How do I get the full Form 483 for KVK-TECH, 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.