Formulation Technology Incorporated
Form 483 issued January 10, 2020 · Oakdale, California
- Inspection
- Jan 6 – Jan 10, 2020
- Investigator
- Scott N. Lim
- Observations
- 2
- Pages
- 3
- FEI number
- 2937960
In short: On January 10, 2020, FDA issued a Form 483 with 2 observations to Formulation Technology Incorporated in Oakdale, California (FEI 2937960) after an inspection that ran Jan 6 – Jan 10, 2020. The investigator was Scott N. Lim. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmFormulation Technology Incorporated history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Formulation Technology Incorporated?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Formulation Technology Incorporated?
Scott N. Lim is named on this Form 483, for the inspection of Jan 6 – Jan 10, 2020. Each investigator has a profile showing what they cite most.
When was Formulation Technology Incorporated inspected by FDA?
The inspection ran Jan 6 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
How do I get the full Form 483 for Formulation Technology Incorporated?
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.