KVK-Tech, Inc.
Form 483 issued March 13, 2020 · Newtown, Pennsylvania
- Inspection
- Feb 4 – Mar 13, 2020
- Investigators
- Michele Gottshall· Nancy M. Espinal
- Observations
- 11
- Pages
- 11
- FEI number
- 3013676321
In short: On March 13, 2020, FDA issued a Form 483 with 11 observations to KVK-Tech, Inc. in Newtown, Pennsylvania (FEI 3013676321) after an inspection that ran Feb 4 – Mar 13, 2020. The investigators were Michele Gottshall and Nancy M. Espinal. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
The entries in the equipment cleaning and use logs are…
- 03
Unauthorized personnel have access to enter areas of the buildings and facilities designated…
- 04
Drug product production and control records, are not reviewed by the quality control unit to determine…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmKVK-Tech, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KVK-Tech, Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected KVK-Tech, Inc.?
Michele Gottshall and Nancy M. Espinal are named on this Form 483, for the inspection of Feb 4 – Mar 13, 2020. Each investigator has a profile showing what they cite most.
When was KVK-Tech, Inc. inspected by FDA?
The inspection ran Feb 4 – Mar 13, 2020, and the Form 483 is dated March 13, 2020.
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.