Form 483 · FEI 2018526
Form 483 issued March 24, 2023 · Chatsworth, California
- Inspection
- Mar 20 – Mar 24, 2023
- Investigator
- Gunneet Kaur
- Observations
- 8
- Pages
- 11
- FEI number
- 2018526
In short: On March 24, 2023, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Chatsworth, California (FEI 2018526) after an inspection that ran Mar 20 – Mar 24, 2023. The investigator was Gunneet Kaur. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
The calibration of instruments and apparatus is not…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
The persons performing and double-checking the cleaning and maintenance are not signing or initialing the equipment…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSite 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 an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Gunneet Kaur is named on this Form 483, for the inspection of Mar 20 – Mar 24, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 20 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.