FDA Inspection
Exela Pharma Sciences LLCExela Pharma Sciences LLC – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Exela Pharma Sciences LLC, with an inspection on March 29, 2019, issued by the Atlanta District Office, covering human drugs.
View Company Profile
ID · 4905f687-c73c-4645-b475-2579c09ea06e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084304
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.182Chronological Order of Equipment Log Entries
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.80(a)Procedures To Be in Writing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Exela Pharma Sciences LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | OAI | Drug Quality Assurance | |
| July 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 11, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 27, 2017 | Not classified | Atlanta District Office |
Other documents for Exela Pharma Sciences LLC
- FDA Inspection 1256957 - 2024-11-15
- FDA Inspection 1096634 - 2019-07-18
- FDA Inspection 1081405 - 2018-12-19
- FDA Inspection 1067755 - 2018-09-11
- FDA Inspection 1032076 - 2017-10-27
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.