Overview
- 7 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Nov 2024
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Samir C Gala, Daniel L Zheng
7 Nov 2024
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Samir C Gala, Daniel L Zheng
7 Nov 2024
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Samir C Gala, Daniel L Zheng
Inspected site
MLMilbar Laboratories, Inc.East Haven, United States
Inspection team
DLDaniel L Zheng
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | 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, 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