Overview
- 12 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
13 Apr 2018
21 CFR 211.160(b)(1)
Incoming lots - conformance to written specs-
Cited by John P Mistler, Erik W Koester
13 Apr 2018
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by John P Mistler, Erik W Koester
13 Apr 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by John P Mistler, Erik W Koester
13 Apr 2018
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by John P Mistler, Erik W Koester
Inspected site
SSSharp Sterile Manufacturing, LLCLee, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 2x |
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 12 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