Premier Magnesia LLC
Form 483 issued July 27, 2022 · Greendale, Indiana
- Inspection
- Jul 14 – Jul 27, 2022
- Investigator
- Logan T. Williams
- Observations
- 7
- Pages
- 9
- FEI number
- 3008635020
In short: On July 27, 2022, FDA issued a Form 483 with 7 observations to Premier Magnesia LLC in Greendale, Indiana (FEI 3008635020) after an inspection that ran Jul 14 – Jul 27, 2022. The investigator was Logan T. Williams. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Critical parameters and quality attributes have not been established. Ranges of operation have not been established…
- 02
Procedures are not in place to prevent incoming material being used in production prior…
- 03
Microbial evaluation has not been performed for the product to know if microbiological specifications should be…
- 04
Cleaning and sanitation of equipment and facilities are…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmPremier Magnesia LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Premier Magnesia LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Premier Magnesia LLC?
Logan T. Williams is named on this Form 483, for the inspection of Jul 14 – Jul 27, 2022. Each investigator has a profile showing what they cite most.
When was Premier Magnesia LLC inspected by FDA?
The inspection ran Jul 14 – Jul 27, 2022, and the Form 483 is dated July 27, 2022.
How do I get the full Form 483 for Premier Magnesia LLC?
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.