Overview
- 10 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Feb 2021
21 CFR 117.145(a)
Allergen Controls Monitoring Proced: Establish Implement
Cited by Gina Eng
25 Feb 2021
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Gina Eng
25 Feb 2021
21 CFR 117.165(b)
Sanitation Controls Verif Procedures: Establish Implement
Cited by Gina Eng
Inspected site
ABAtlantic Bakery Ltd.Delray Beach, United States
Inspection team
GEGina Eng
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.415(a)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 10 observations
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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