Copperhead Chemical Company Inc.
Form 483 issued April 24, 2023 · Tamaqua, Pennsylvania
- Inspection
- Apr 17 – Apr 24, 2023
- Investigator
- Brandy N. Lepage
- Observations
- 3
- Pages
- 4
- FEI number
- 2517101
In short: On April 24, 2023, FDA issued a Form 483 with 3 observations to Copperhead Chemical Company Inc. in Tamaqua, Pennsylvania (FEI 2517101) after an inspection that ran Apr 17 – Apr 24, 2023. The investigator was Brandy N. Lepage. 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
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCopperhead Chemical Company Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Copperhead Chemical Company Inc.?
FDA listed 3 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 Copperhead Chemical Company Inc.?
Brandy N. Lepage is named on this Form 483, for the inspection of Apr 17 – Apr 24, 2023. Each investigator has a profile showing what they cite most.
When was Copperhead Chemical Company Inc. inspected by FDA?
The inspection ran Apr 17 – Apr 24, 2023, and the Form 483 is dated April 24, 2023.
How do I get the full Form 483 for Copperhead Chemical Company Inc.?
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