Neutraderm, Inc.
Form 483 issued December 9, 2022 · Chastsworth, California
- Inspection
- Dec 5 – Dec 9, 2022
- Investigator
- Gunneet Kaur
- Observations
- 6
- Pages
- 8
- FEI number
- 3006402197
In short: On December 9, 2022, FDA issued a Form 483 with 6 observations to Neutraderm, Inc. in Chastsworth, California (FEI 3006402197) after an inspection that ran Dec 5 – Dec 9, 2022. The investigator was Gunneet Kaur. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do…
- 03
Written records of major equipment cleaning, maintenance and use are not included…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
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 firmNeutraderm, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neutraderm, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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 Neutraderm, Inc.?
Gunneet Kaur is named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Neutraderm, Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for Neutraderm, 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.