Overview
- 9 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Dec 2022
FDCA 501(a)(2)(A)
Beta-lactam drugs, inadequate sanitation
Cited by Jonathan G Matrisciano, Daniel J Min
9 Dec 2022
FDCA 501(a)(2)(A)
Cleanliness, ISO-classified areas
Cited by Jonathan G Matrisciano, Daniel J Min
9 Dec 2022
FDCA 501(a)(2)(A)
First pass air blockage, open unit with sterile product
Cited by Jonathan G Matrisciano, Daniel J Min
9 Dec 2022
FDCA 501(a)(2)(A)
Hazardous drugs, prevention of cross-contamination
Cited by Jonathan G Matrisciano, Daniel J Min
9 Dec 2022
FDCA 501(a)(2)(A)
Improper gowning, contamination
Cited by Jonathan G Matrisciano, Daniel J Min
Inspected site
APAkina PharmacySterling, 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 | 9x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 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