Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
17 Mar 2023
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
Inspected site
SPSaptalis Pharmaceuticals LLCHauppauge, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 2x |
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 8 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