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User Access and Controls
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records Cipla Limited |
21 Jun 2024 | Normal | Justification: The observation points to inadequate control and assignment of user privileges, directly linking to User Access and Controls. Excerpt: User privileges assigned within the manufacturing equipment used for products intended for the US market are not appropriate for the job functions being performed nor are they adequately defined. View Details |
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: The observation highlights weaknesses in user access management and the use of shared accounts, which are central to user access and control processes. Excerpt: Your firm’s NetSCADA software used to operate (b) (4) all users have access to a non-specific administrator-level account. View Details |
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Carma Laboratories, Inc. |
14 Nov 2023 | Normal | Justification: The enabled deletion function and unauthorized access suggests a breakdown in user access control procedures. Excerpt: The delete functions are enabled in all your laboratory computer systems... View Details |
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. NATCO Pharma Limited |
18 Oct 2023 | Normal | Justification: The observation specifically mentions unauthorized access by production operators and the lack of assigned user roles, indicating a fundamental issue with user access and controls. Excerpt: Production Operator accessed this machine using user access. Further investigation indicated the equipment has fifteen listed users and the "Operator" access is not assigned to anyone of them. View Details |
| Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy. Central Admixture Pharmacy Services Inc |
25 Aug 2023 | Normal | Justification: The unauthorized use signifies a lapse in user access management controls during technician absences. Excerpt: "I was on vacation and was locked out." View Details |
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