Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Aug 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
9 Aug 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
9 Aug 2022
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
9 Aug 2022
21 CFR 211.192
No written record of investigation
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
9 Aug 2022
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
Inspected site
PIProfounda IncOrlando, 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 | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 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