Cutibacterium acnes Associated Form 483s
| Date 483 Issued | Firm/Type of Manufacturing | Description |
|---|---|---|
| 10/26/2000 | BioPort Corp./Vaccine/blood products | Cutibacterium acnes recovered in anthrax vaccine sterility test |
| 10/26/2012 | Apotex Inc./Sterile ophthalmic and unsterile drug products | Cutibacterium acnes recovered in unsterile filling line lubricant |
| 06/20/2012 | Asept Pak Inc./Medical device and drug products | Cutibacterium acnes recovered in sterile filling sodium chloride for inhalation |
| 04/09/2014 | ID Biomedical Corp of Quebec d/b/a GSK/Vaccines | Sterility tests fail due to contamination with Cutibacterium acnes. Inadequate controls preventing personnel contamination of sterility test samples; Cutibacterium acnes from personnel handling was identified |
| 04/10/2015 | Sigma-Tau Pharmasource, Inc./Sterile drug products | Inadequate assurance that the environmental monitoring program (D/E neutralizing agar, TSA, aerobic incubation) recovers Cutibacterium acnes previously isolated during baseline studies using CDC media |
| 09/17/2015 | Qualgen LLC./Out sourcing facility | Cutibacterium acnes recovered in vaccine sterility test |
| 07/19/2017 | CSL Behring, LLC./Biological drug products | Cutibacterium acnes recovered in turbid process simulation vials |
| Failure to thoroughly evaluate if Cutibacterium acnes could be detected in the environment | ||
| Failure to demonstrate that Cutibacterium acnes can be recovered in personnel and surface monitoring media |