Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
21 Jun 2012
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Angela E Glenn
21 Jun 2012
21 CFR 111.35(b)(6)
Documentation - equipment functions; intended use
Cited by Angela E Glenn
Inspected site
PLPharmco Laboratories Inc.Titusville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.117(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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