KVK-TECH, INC.
Form 483 issued July 8, 2022 · NEWTOWN, Pennsylvania
- Inspection
- Jun 21 – Jul 8, 2022
- Investigators
- Jose M. Cayuela· Monika Borkowska· Saleem A. Akhtar
- Observations
- 10
- Pages
- 17
- FEI number
- 3005117563
In short: On July 8, 2022, FDA issued a Form 483 with 10 observations to KVK-TECH, INC. in NEWTOWN, Pennsylvania (FEI 3005117563) after an inspection that ran Jun 21 – Jul 8, 2022. The investigators were Jose M. Cayuela, Monika Borkowska and Saleem A. Akhtar. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) 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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KVK-TECH, INC.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected KVK-TECH, INC.?
Jose M. Cayuela, Monika Borkowska and Saleem A. Akhtar are named on this Form 483, for the inspection of Jun 21 – Jul 8, 2022. Each investigator has a profile showing what they cite most.
When was KVK-TECH, INC. inspected by FDA?
The inspection ran Jun 21 – Jul 8, 2022, and the Form 483 is dated July 8, 2022.
How do I get the full Form 483 for KVK-TECH, INC.?
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