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Material Receipt and Handling
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use. Nubratori, Inc |
26 Jul 2024 | Normal | Justification: Handling and receiving processes are implicated due to failures in checking critical quality attributes for incoming materials. Excerpt: Acceptance of incoming lots of non-sterile component for use in sterile drug products must include microbial and endotoxin testing... View Details |
| Establishment of the reliability of the component supplier's report of analyses is deficient Nubratori, Inc |
26 Jul 2024 | Normal | Justification: Handles the procedural compliance related to the reception and testing of raw materials. Excerpt: Your firm failed to conduct full testing as part of the Bulk Drug Substance (BDS) re-qualification of supplier qualification. View Details |
| Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures. Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: Material Receipt and Handling is closely related to the observation, as the main issue involves improper documentation and coding of received materials. Excerpt: Failed to follow procedure SOP-U3MB033.03 which requires fully recording Material Receipt Reports for all Components, Drug Product Containers and closures received. View Details |
| Use of ingredients not intended for pharmaceutical use in sterile drug production. Empower Clinic Services, LLC, dba Empower Pharmacy |
01 Dec 2023 | Normal | Justification: The observation highlights issues in the receipt and handling of materials, specifically the acceptance and use of unapproved materials. Excerpt: Your firm used the 'Not for Use as Drug/API or Drug Product' to compound the following sterile drug product... View Details |
| Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B Hybrid Pharma LLC |
09 Nov 2023 | Normal | Justification: The issue is directly related to the improper handling and verification processes associated with material receipt and handling, leading to the unauthorized compounding of drug products. Excerpt: Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B. View Details |
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