Weckerle Cosmetics USA, Inc
Form 483 issued March 26, 2021 · Torrance, California
- Inspection
- Mar 22 – Mar 26, 2021
- Investigators
- Jeffrey P. Raimondi· Khoa Nathan V. Tran
- Observations
- 9
- Pages
- 5
- FEI number
- 3000207078
In short: On March 26, 2021, FDA issued a Form 483 with 9 observations to Weckerle Cosmetics USA, Inc in Torrance, California (FEI 3000207078) after an inspection that ran Mar 22 – Mar 26, 2021. The investigators were Jeffrey P. Raimondi and Khoa Nathan V. Tran. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
EMPLOYEE{S) SIGNATURE Establishment of the reliability of the component supplier's report of analyses is deficient in…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmWeckerle Cosmetics USA, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Weckerle Cosmetics USA, Inc?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Weckerle Cosmetics USA, Inc?
Jeffrey P. Raimondi and Khoa Nathan V. Tran are named on this Form 483, for the inspection of Mar 22 – Mar 26, 2021. Each investigator has a profile showing what they cite most.
When was Weckerle Cosmetics USA, Inc inspected by FDA?
The inspection ran Mar 22 – Mar 26, 2021, and the Form 483 is dated March 26, 2021.
How do I get the full Form 483 for Weckerle Cosmetics USA, 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.