Investigator Details
Brandon C Heitmeier
Investigation Details
Last Issued Date:
April 20, 2022
Conversion Rate:
7
No. of 483’s Issued :
14
Warning Letters Issued:
1
Detailed Analysis
Approach:
He seems to pay meticulous attention to quality control and record-keeping. His investigation style appears to be systematic, broad-ranging, and firmly rooted in adherence to regulatory requirements.
Profile:
FDA Investigator, Brandon C Heitmeier, seems to give significant attention towards the microbial detection processes, the validation of aseptic processes, and the documentation and record keeping. There is also a clarity in approach to check miscellaneous compliance areas like inappropriate usage of unapproved bulk drugs. He values the adopting of accurate and verifiable processes in all stages of production/testings, reinforcing the adherence of the FDA-approved procedures.
Top Process Types:
- Document Management
- Investigations
- Compliance Management
- Material Receipt and Handling
- Media Fill
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Nephron Sterile Compounding Center LLC
Drugs
