KVK-TECH, INC.
Form 483 issued June 11, 2021 · NEWTOWN, Pennsylvania
- Inspection
- May 25 – Jun 11, 2021
- Investigators
- Junho Pak· Karen A. Briggs· Michele Gottshall
- Observations
- 8
- Pages
- 9
- FEI number
- 3005117563
In short: On June 11, 2021, FDA issued a Form 483 with 8 observations to KVK-TECH, INC. in NEWTOWN, Pennsylvania (FEI 3005117563) after an inspection that ran May 25 – Jun 11, 2021. The investigators were Junho Pak, Karen A. Briggs and Michele Gottshall. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 7 of 8 observations.
Most cited: 21 CFR 211.22 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KVK-TECH, INC.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected KVK-TECH, INC.?
Junho Pak, Karen A. Briggs and Michele Gottshall are named on this Form 483, for the inspection of May 25 – Jun 11, 2021. Each investigator has a profile showing what they cite most.
When was KVK-TECH, INC. inspected by FDA?
The inspection ran May 25 – Jun 11, 2021, and the Form 483 is dated June 11, 2021.
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.