Azurity Pharmaceuticals, Inc.
Form 483 issued February 24, 2022 · Wilmington, Massachusetts
- Inspection
- Feb 14 – Feb 24, 2022
- Observations
- 3
- Pages
- 4
- FEI number
- 3003395329
In short: On February 24, 2022, FDA issued a Form 483 with 3 observations to Azurity Pharmaceuticals, Inc. in Wilmington, Massachusetts (FEI 3003395329) after an inspection that ran Feb 14 – Feb 24, 2022. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Sampling procedures are deficient regarding sampling components from the top, middle…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Questions about this 483
What did FDA find at Azurity Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment 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.
When was Azurity Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 14 – Feb 24, 2022, and the Form 483 is dated February 24, 2022.
How do I get the full Form 483 for Azurity Pharmaceuticals, Inc.?
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