Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
3 Jun 2016
21 CFR 211.166(a)
Lack of written stability program
Cited by Anh Lac, Stephanie A Slater, Henry K Lau
3 Jun 2016
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Anh Lac, Stephanie A Slater, Henry K Lau
3 Jun 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Anh Lac, Stephanie A Slater, Henry K Lau
3 Jun 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Anh Lac, Stephanie A Slater, Henry K Lau
Inspected site
JIJajco, Inc. DBA Anchor Drugs PharmacySouth San Francisco, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
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 7 observations
The source PDF and every observation in full, 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