Shine & Pretty (USA), Corp.
Form 483 issued March 4, 2020 · Camarillo, California
- Inspection
- Feb 18 – Mar 4, 2020
- Investigator
- Taichun Qin
- Observations
- 5
- Pages
- 4
- FEI number
- 2027711
In short: On March 4, 2020, FDA issued a Form 483 with 5 observations to Shine & Pretty (USA), Corp. in Camarillo, California (FEI 2027711) after an inspection that ran Feb 18 – Mar 4, 2020. The investigator was Taichun Qin. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written records are not made of…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmShine & Pretty (USA), Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shine & Pretty (USA), Corp.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Shine & Pretty (USA), Corp.?
Taichun Qin is named on this Form 483, for the inspection of Feb 18 – Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was Shine & Pretty (USA), Corp. inspected by FDA?
The inspection ran Feb 18 – Mar 4, 2020, and the Form 483 is dated March 4, 2020.
How do I get the full Form 483 for Shine & Pretty (USA), Corp.?
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.