Giles Chemical, a Division of Premier Magnesia LLC
Form 483 issued November 9, 2018 · Waynesville, North Carolina
- Inspection
- Nov 6 – Nov 9, 2018
- Investigator
- Christopher Keating
- Observations
- 9
- Pages
- 6
- FEI number
- 1044794
In short: On November 9, 2018, FDA issued a Form 483 with 9 observations to Giles Chemical, a Division of Premier Magnesia LLC in Waynesville, North Carolina (FEI 1044794) after an inspection that ran Nov 6 – Nov 9, 2018. The investigator was Christopher Keating. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.125 (2×) · 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
No effective controls are in-place to prevent the reprocessing of nonconforming Magnesium Sulfate USP material contaminated…
- 02
Written procedures are not…
- 03
Strict control is not exercised over labeling issued for use in…
- 04
Written records are not always made of…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmGiles Chemical, a Division of Premier Magnesia LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Giles Chemical, a Division of Premier Magnesia LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected Giles Chemical, a Division of Premier Magnesia LLC?
Christopher Keating is named on this Form 483, for the inspection of Nov 6 – Nov 9, 2018. Each investigator has a profile showing what they cite most.
When was Giles Chemical, a Division of Premier Magnesia LLC inspected by FDA?
The inspection ran Nov 6 – Nov 9, 2018, and the Form 483 is dated November 9, 2018.
How do I get the full Form 483 for Giles Chemical, a Division of 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.