Overview
- 12 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 7 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Mixtures: uniformity and concentration
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Conduct: identification of test specimens
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Final report: names of those involved
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Management: personnel understand their functions
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Study director: all data recorded and verified
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(f) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 12 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