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Area Qualification
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Your firm failed to perform adequate smoke studies under dynamic conditions Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: Area Qualification is implicated as the observation highlights the failure to confirm airflow adequacy in critical clean areas. Excerpt: Your firm failed to perform adequate smoke studies...risk of contamination. View Details |
| Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Belcher Pharmaceuticals, LLC |
16 Aug 2024 | Normal | Justification: Failure to meet specified air quality due to inadequate area qualification practices. Excerpt: fail to certify the following production rooms... do not meet ISO 8 specifications View Details |
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. ProRx LLC |
02 Aug 2024 | Normal | Justification: Proper area qualification ensures contamination risk is minimized across different class environments. Excerpt: Your firm does not have a defined minimum differential pressure between ISO 7 spaces and unclassified spaces. View Details |
| Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed Hikma Pharmaceuticals USA Inc. |
12 Jun 2024 | Normal | Justification: Area qualification is critical since the inadequacies in the current protocols reflect improper environmental qualification. Excerpt: Your air visualization 'smoke' studies utilized by your firm to qualify your controlled environment revealed deficiencies. View Details |
| Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size and construction to facilitate cleaning, maintenance, and proper operations Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: Area qualification should be documented thoroughly to ensure all specifications and requirements are met and verifiable. Excerpt: Your firm had no documentation or data to demonstrate that the rooms in your aseptic processing area, including Grade C areas, met your firm’s specifications. View Details |
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