FDA Inspection
Aesica Pharmaceuticals GmbHAesica Pharmaceuticals GmbH – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Aesica Pharmaceuticals GmbH, with an inspection on December 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 3df675b2-3eea-44d0-834f-97f0db529daa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994783
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aesica Pharmaceuticals GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aesica Pharmaceuticals GmbH
- FDA Inspection 1277716 - 2023-08-31
- FDA Inspection 1105950 - 2019-08-30
- FDA Inspection 887354 - 2014-06-20
- FDA Inspection 759166 - 2011-11-08
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.