Food and Drug Administration (FDA) officials inspect pharmacies since they are an FDA-regulated industry. Complaints made by consumers, special investigations, and standard inspections are all reasons an inspection might occur. Inspections are not always scheduled, and FDA agents have the authority to enter your facility at any moment.
Since there is a lot at risk when FDA inspections occur, many pharmacies find the help of a knowledgeable attorney invaluable.
Assistance with Preparation
There is no better way to prepare for an inspection than to run your routine activities according to a well-implemented compliance strategy. An FDA inspection should not be a source of concern if your pharmacy is in complete compliance each day.
Pharmacy FDA inspection attorneys can assist clients with their compliance procedures and provide advice on any areas that fall short of standards. Experienced attorneys also work with pharmacies that have just undergone inspection and advise them on steps to avoid more substantial FDA proceedings.
FDA Pharmacy Inspections: What to Expect
Inspections may involve assessing sterile practices, ensuring the 503A exemption is satisfied and responding to a consumer complaint. Although the FDA may notify the pharmacy to ensure that documents and the right personnel are available for the inspection, for-cause inspections are rarely announced.
To inspect a facility, the FDA needs an inspection warrant.
Note: The presence of police enforcement during the search may indicate that the FDA is seeking proof of illegal activity.
It is critical to have an attorney present in the event of an FDA inspection. A legal team may be able to work with the FDA to postpone inspection until your attorney arrives.
Inspections by the FDA should be confined to records relating to alleged infractions. The presence of an attorney from Hasson Law Group LLP can help prevent the FDA from going beyond the limits of the primary purpose of the inspection.
The following are some common FDA violations found at pharmacies:
- Workers who are not properly sterilized or gowned
- Inadequate air quality or failure to maintain air sample logs
- Inadequate incubator temperature or a lack of temperature records
- Failure to retain proper prescription records
After the inspection, the FDA inspector will issue documentation with a list of any violations discovered. At this stage, our legal experts can assist you in ensuring that the problems are corrected as soon as possible before the FDA takes disciplinary action.
For more serious offenses, such as those posing a health danger or putting the public’s health at risk, the court can impose injunctions and temporary restraining orders. Finally, criminal charges and revocation of licensing can occur in the most serious cases.
Don’t Face an FDA Pharmacy Inspection Alone
Hasson Law Group LLP‘s attorneys are knowledgeable of FDA inspection procedures, and we have successfully defended many pharmaceutical professionals facing accusations and discipline. We support our clients at every level of the process to safeguard their rights and deliver the best results. Contact us at 678-701-2869.
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