Sunrider Manufacturing L P
Form 483 issued July 3, 2019 · Torrance, California
- Inspection
- Jun 17 – Jul 3, 2019
- Investigator
- Stephanie A. Slater
- Observations
- 1
- Pages
- 13
- FEI number
- 1000125398
In short: On July 3, 2019, FDA issued a Form 483 with 1 observation to Sunrider Manufacturing L P in Torrance, California (FEI 1000125398) after an inspection that ran Jun 17 – Jul 3, 2019. The investigator was Stephanie A. Slater. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmSunrider Manufacturing L P history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunrider Manufacturing L P?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Sunrider Manufacturing L P?
Stephanie A. Slater is named on this Form 483, for the inspection of Jun 17 – Jul 3, 2019. Each investigator has a profile showing what they cite most.
When was Sunrider Manufacturing L P inspected by FDA?
The inspection ran Jun 17 – Jul 3, 2019, and the Form 483 is dated July 3, 2019.
How do I get the full Form 483 for Sunrider Manufacturing L P?
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.