Overview
- 9 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Mar 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin
6 Mar 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin
6 Mar 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin
6 Mar 2026
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin
6 Mar 2026
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Daniel T Lee, Tanya R Syffrard, Pushpa S Jayasekara, Michelle Lin
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 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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