Giles Chemical, a Division of Premier Magnesia LLC
FDA inspection history in Waynesville, North Carolina, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Waynesville, North Carolina.
Cited most
Across all Giles Chemical, a Division of Premier Magnesia observations on file
- 21 CFR 211.125Labeling issuance2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.115Reprocessing1
The complete Giles Chemical, a Division of Premier Magnesia file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Waynesville, North Carolina
One Form 483 · 2018 · 9 observations
Latest: Form 483, Nov 9, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-09 | 483 Form 483 | Waynesville, North Carolina | 9 | $99 |
Investigators on these documents
FEI number 1044794 · most recent document Nov 9, 2018
About Giles Chemical, a Division of Premier Magnesia LLC
How many FDA Form 483s has Giles Chemical, a Division of Premier Magnesia LLC received?
FDA Intel has 1 Form 483 on file for Giles Chemical, a Division of Premier Magnesia LLC; the most recent is dated Nov 9, 2018.
When was Giles Chemical, a Division of Premier Magnesia LLC last inspected by FDA?
The most recent FDA inspection document on file for Giles Chemical, a Division of Premier Magnesia LLC is a Form 483 dated Nov 9, 2018, for the site in Waynesville, North Carolina.
What did FDA cite at Giles Chemical, a Division of Premier Magnesia LLC?
The regulations cited most in the observations on file for Giles Chemical, a Division of Premier Magnesia LLC are 21 CFR 211.125 (Labeling issuance), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.