Overview
- 6 public-safe observations are available for this inspection.
- 5 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.
1 Jun 2026
21 CFR 1271.47(a)
Design of procedures to ensure compliance
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.50(b)(1)
Donor screening standards
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Elyshia Q Danaher, Ashleigh M Robertson
1 Jun 2026
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Elyshia Q Danaher, Ashleigh M Robertson
Inspected site
MAMichael A. Allon, M.D, P.A.Houston, United States
Inspection team
AMAshleigh M Robertson
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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