Best Formulations, Inc
Form 483 issued June 12, 2019 · City Of Industry, California
- Inspection
- Jun 4 – Jun 12, 2019
- Investigator
- Uttaniti Limchumroon
- Observations
- 5
- Pages
- 7
- FEI number
- 3003121131
In short: On June 12, 2019, FDA issued a Form 483 with 5 observations to Best Formulations, Inc in City Of Industry, California (FEI 3003121131) after an inspection that ran Jun 4 – Jun 12, 2019. The investigator was Uttaniti Limchumroon. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmBest Formulations, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Best Formulations, Inc?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Best Formulations, Inc?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Jun 4 – Jun 12, 2019. Each investigator has a profile showing what they cite most.
When was Best Formulations, Inc inspected by FDA?
The inspection ran Jun 4 – Jun 12, 2019, and the Form 483 is dated June 12, 2019.
How do I get the full Form 483 for Best Formulations, 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.