Regulatory
Chattem holds four DEA registrations that cover bulk manufacturing, importing, exporting,
and analytical activities for controlled substances schedules 1 through 5. Chattem has an in-house DEA regulatory
expert proficient in 21 CFR regulations, drug code additions to DEA registrations, import and export requirements,
and quota applications. Regulatory compliance spans site-wide, as Chattem’s DEA audit history displays successful
audits with zero observations.
Chattem has a strong history of meeting and exceeding regulatory requirements. Chattem has
regulatory experts on site to make sure there are no unforeseen issues that arise to compromise your project as well
as access to regulatory experts through Sun Pharma’s global network of personnel. With experience performing various
submissions globally and the capability to support custom projects, Chattem’s regulatory department is the final
step to helping get your API to market.
2023
- DEA Inspection – No Issues
2022
- FDA General Inspection – 0 Observations on a 483
- DEA Inspection – No Issues
2018
- FDA General Inspection – 4 Observations on a 483, EIR Received; Inspection Closed
- 3 DEA Inspections – No Issues
2017
- 5 DEA Inspections – No Issues
2016
- FDA PAI—Product Specific No observations
2015
- DEA Inspection – No Issues
2014
- 4 Observations on a 483, EIR Received; Inspection Closed
2013
- DEA Inspection – No Issues
2011
- FDA Inspection – 4 Observations on a 483, EIR Received; Inspection Closed
- DEA Inspection – No Issues
2010
- DEA Inspection – No Issues
- FDA Inspection Zero 483 2nd Zero
2008
- DEA Inspection – No Issues
- FDA Inspection Zero 483