Precious Cosmetics Packaging and
Form 483 issued April 1, 2019 · Lodi, New Jersey
- Inspection
- Mar 26 – Apr 1, 2019
- Investigator
- Helen Verdel
- Observations
- 8
- Pages
- 4
- FEI number
- 3013173967
In short: On April 1, 2019, FDA issued a Form 483 with 8 observations to Precious Cosmetics Packaging and in Lodi, New Jersey (FEI 3013173967) after an inspection that ran Mar 26 – Apr 1, 2019. The investigator was Helen Verdel. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 8 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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 04
The batch production and control records are deficient in that they are not an accurate reproduction…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmPrecious Cosmetics Packaging and history
The site's inspection history, in date order.
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 Precious Cosmetics Packaging and?
FDA listed 8 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 Precious Cosmetics Packaging and?
Helen Verdel is named on this Form 483, for the inspection of Mar 26 – Apr 1, 2019. Each investigator has a profile showing what they cite most.
When was Precious Cosmetics Packaging and inspected by FDA?
The inspection ran Mar 26 – Apr 1, 2019, and the Form 483 is dated April 1, 2019.
How do I get the full Form 483 for Precious Cosmetics Packaging and?
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.