FDA Inspection
B.M.P. Bulk Medicines & Pharmaceuticals GmbHB.M.P. Bulk Medicines & Pharmaceuticals GmbH – FDA Inspection, Nov 16, 2011
Record Details
This FDA Inspection record concerns B.M.P. Bulk Medicines & Pharmaceuticals GmbH, with an inspection on November 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 16, 2011
- Product Type
- Drugs
View Company Profile
ID · 20209079-cc02-4b83-9d46-1a8c6dcb64ce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 759793
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.