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Facility Design
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: The observation highlights poor maintenance which is a fundamental aspect of facility design affecting production areas. Excerpt: Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair. View Details |
| Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Facility Design impacts environmental controls; absence of indicators between rooms is a design shortcoming. Excerpt: There was no alarm, light, or device providing an indication and measurement of a change in differential pressure. View Details |
| Aseptic processing areas are deficient in that are not smooth and/or hard surfaces that are easily cleanable. Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: The observation details surface damage and residue, indicating that facility design elements like materials used are not fit. Excerpt: Aseptic processing areas are deficient in that are not smooth and/or hard surfaces that are easily cleanable. View Details |
| Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction Mark Cuban Cost Plus Manufacturing and Compounding LLC |
06 Sep 2024 | Normal | Justification: The issue is directly linked to facility design due to improper infrastructure allowing contamination risks. Excerpt: Your firm's ISO 7 Filling Room (RM 034) containing your ISO 5 (b) (4) Fill (b) (4) is designed with exposed sprinkler heads within the room ceiling. View Details |
| Building and facilities are not maintained to ensure that products manufactured meet the quality Granules India Limited |
06 Sep 2024 | Normal | Justification: Observation discusses poor facility maintenance, specifically mentioning damaged filters and contaminated areas. Excerpt: filters of vour randomly selected Air Purification Units... were severely damaged and torn in many sections. View Details |
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