Cosette Pharmaceuticals NC Laboratories, LLC
Form 483 issued July 21, 2023 · Lincolnton, North Carolina
- Inspection
- Jul 17 – Jul 21, 2023
- Observations
- 2
- Pages
- 3
- FEI number
- 1053439
In short: On July 21, 2023, FDA issued a Form 483 with 2 observations to Cosette Pharmaceuticals NC Laboratories, LLC in Lincolnton, North Carolina (FEI 1053439) after an inspection that ran Jul 17 – Jul 21, 2023. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(1) (1×) · 211.80(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 02
Written procedures are not followed for the storage…
This inspection in context
Questions about this 483
What did FDA find at Cosette Pharmaceuticals NC Laboratories, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Cosette Pharmaceuticals NC Laboratories, LLC inspected by FDA?
The inspection ran Jul 17 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
How do I get the full Form 483 for Cosette Pharmaceuticals NC Laboratories, LLC?
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