Overview
- 7 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
19 Oct 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.198(a)
Complaints reviewed by Quality Control Unit
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ucheabuchi C Chudi-Nwankwor
19 Oct 2023
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Ucheabuchi C Chudi-Nwankwor
Inspected site
AIAlkermes, IncWilmington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 7 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere