Overview
- 5 public-safe observations are available for this inspection.
- 3 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.
9 May 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jennifer L Huntington
9 May 2019
FDCA 501(a)(2)(A)
Actionable microbial contamination, adjacent area
Cited by Jennifer L Huntington
9 May 2019
FDCA 501(a)(2)(A)
Disinfecting and cleaning agents, ISO 5 area
Cited by Jennifer L Huntington
Inspected site
CQCoast Quality Pharmacy LLCTampa, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(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 5 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