Regulatory Responses

Has the FDA come to your location? Are they asking for documents that you suspect they shouldn’t ask for? Are you concerned that they might shut down your facility? Stop!! Fear no more!!

We have responded, on behalf of our clients, to multiple FDA inspections and advised our clients on appropriate ways to respond to minimize risk. Steps have included developing standard operating procedures and training, negotiating with the FDA and developing quality agreements.

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None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.