Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Mar 2022
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Matthew A Johnson, Jennifer M Pouget
15 Mar 2022
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Matthew A Johnson, Jennifer M Pouget
15 Mar 2022
21 CFR 111.75(c)(4)
Documentation - specifications met; basis, quality control
Cited by Matthew A Johnson, Jennifer M Pouget
Inspected site
PLPharmachem Laboratories LLCOgden, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.605(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(4) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
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Form 483 source document
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Full 483 report
Get the verbatim text of all 4 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