Overview
- 12 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Mar 2020
21 CFR 211.111
Establishment of time limitations
Cited by John P Mistler, Erik W Koester, Jonah S Ufferfilge, Samir C Gala
30 Mar 2020
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by John P Mistler, Erik W Koester, Jonah S Ufferfilge, Samir C Gala
30 Mar 2020
21 CFR 211.166(a)
Written program not followed
Cited by John P Mistler, Erik W Koester, Jonah S Ufferfilge, Samir C Gala
30 Mar 2020
21 CFR 211.167(a)
Sterility/pyrogens - test methods written, followed
Cited by John P Mistler, Erik W Koester, Jonah S Ufferfilge, Samir C Gala
30 Mar 2020
21 CFR 211.192
Investigations of discrepancies, failures
Cited by John P Mistler, Erik W Koester, Jonah S Ufferfilge, Samir C Gala
Inspected site
EPEdge Pharmacy Services, LLCColchester, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 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 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | 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 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