Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
21 May 2024
21 CFR 600.10(b)
Personnel capabilities
Cited by Fabian N Chaparro-Rodriguez, Laura E Garcia, Nerming V Briones
21 May 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Fabian N Chaparro-Rodriguez, Laura E Garcia, Nerming V Briones
21 May 2024
21 CFR 606.100(c)
Thorough investigations
Cited by Fabian N Chaparro-Rodriguez, Laura E Garcia, Nerming V Briones
21 May 2024
21 CFR 606.140(a)
Establishment of spec., standards, and test procedures
Cited by Fabian N Chaparro-Rodriguez, Laura E Garcia, Nerming V Briones
21 May 2024
21 CFR 606.140(c)
Adequate identification and handling of test samples
Cited by Fabian N Chaparro-Rodriguez, Laura E Garcia, Nerming V Briones
Inspected site
CSContinental Services Group, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.40(h)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.41 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.30(a)(3) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 11 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