Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation
Form 483 issued February 21, 2025 · College Park, Georgia
- Observations
- 5
- Pages
- 4
- FEI number
- 1000110937
In short: On February 21, 2025, FDA issued a Form 483 with 5 observations to Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation in College Park, Georgia (FEI 1000110937). Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with…
- 03
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Questions about this 483
What did FDA find at Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
When was Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation inspected by FDA?
This Form 483 is dated February 21, 2025.
How do I get the full Form 483 for Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation?
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.