Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
18 Jul 2014
21 CFR 111.35(b)(3)
Instruments, controls; calibrate date, reference std, method
Cited by Meredith P Soehl, Andrew J Garufi, Charanjeet Jassal
18 Jul 2014
21 CFR 111.73
Specifications met - identity, purity, strength, composition
Cited by Meredith P Soehl, Andrew J Garufi, Charanjeet Jassal
18 Jul 2014
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Meredith P Soehl, Andrew J Garufi, Charanjeet Jassal
18 Jul 2014
21 CFR 111.260(l)(4)
Batch record - approved, released, rejected
Cited by Meredith P Soehl, Andrew J Garufi, Charanjeet Jassal
18 Jul 2014
21 CFR 111.320(b)
Examination, testing; scientifically valid
Cited by Meredith P Soehl, Andrew J Garufi, Charanjeet Jassal
Inspected site
APAJES Pharmaceuticals, LLCCopiague, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.360 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
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