Sanitor Corporation
Form 483 issued June 3, 2021 · Stanton, California
- Inspection
- May 25 – Jun 3, 2021
- Investigators
- Hung H. Do· Khoa Nathan V. Tran
- Observations
- 13
- Pages
- 9
- FEI number
- 3005871025
In short: On June 3, 2021, FDA issued a Form 483 with 13 observations to Sanitor Corporation in Stanton, California (FEI 3005871025) after an inspection that ran May 25 – Jun 3, 2021. The investigators were Hung H. Do and Khoa Nathan V. Tran. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 8 of 13 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Employees engaged in the processing and packing of a drug product lack the training required to…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSanitor Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Sanitor Corporation?
FDA listed 13 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sanitor Corporation?
Hung H. Do and Khoa Nathan V. Tran are named on this Form 483, for the inspection of May 25 – Jun 3, 2021. Each investigator has a profile showing what they cite most.
When was Sanitor Corporation inspected by FDA?
The inspection ran May 25 – Jun 3, 2021, and the Form 483 is dated June 3, 2021.
How do I get the full Form 483 for Sanitor Corporation?
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.