Overview
- 7 public-safe observations are available for this inspection.
- 6 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.
28 Apr 2010
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Hala L Selby, Anita R Michael, Julianne C Mccullough, George Pyramides
28 Apr 2010
21 CFR 111.165(c)(3)
Product received - quality control; quarantine; release
Cited by Hala L Selby, Anita R Michael, Julianne C Mccullough, George Pyramides
28 Apr 2010
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Hala L Selby, Anita R Michael, Julianne C Mccullough, George Pyramides
28 Apr 2010
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Hala L Selby, Anita R Michael, Julianne C Mccullough, George Pyramides
28 Apr 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Hala L Selby, Anita R Michael, Julianne C Mccullough, George Pyramides
Inspected site
PHPPL Healthcare LLCSellersville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.165(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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