Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Mar 2024
21 CFR 606.60(a)
Provide proper equipment to meet requirements
Cited by Ramon L Gonzalez-Prieto
Inspected site
OPOctapharma Plasma, Inc.Dallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Source document
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- 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