Overview
- 55 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Nov 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by David A Oluwo, James M Simpson, Michael Shanks, Simone E Pitts, Alice S Tsao, Alison N Stieg
9 Nov 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by David A Oluwo, James M Simpson, Michael Shanks, Simone E Pitts, Alice S Tsao, Alison N Stieg
9 Nov 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by David A Oluwo, James M Simpson, Michael Shanks, Simone E Pitts, Alice S Tsao, Alison N Stieg
9 Nov 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by David A Oluwo, James M Simpson, Michael Shanks, Simone E Pitts, Alice S Tsao, Alison N Stieg
9 Nov 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by David A Oluwo, James M Simpson, Michael Shanks, Simone E Pitts, Alice S Tsao, Alison N Stieg
Inspected site
PIPharmaceutics International, Inc.Cockeysville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
Full 483 report
Get the verbatim text of all 55 observations
Every observation in full, 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