Late last month, the FDA finalized a new guidance document, explaining the agency's current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
The ...
Written by Guest Bloggers: Amanda R. Strainis-Walker and Eric J. Conn
Below is a set of important questions that we are frequently asked by clients when OSHA unexpectedly shows up at their doorsteps. These questions and many more are also addressed in our OSHA Inspection Checklist desk reference guide.
Scenario 1: An OSHA Compliance Safety and Health Officer (CSHO) arrives unannounced to begin an inspection, but the employer’s representative whom the employer desires to manage the OSHA inspection is not present at the workplace. Can the employer request that the CSHO return later ...
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