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.
8 Jan 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Raquel Gonzalez Rivera, Jose R Lopez
8 Jan 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Raquel Gonzalez Rivera, Jose R Lopez
8 Jan 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Raquel Gonzalez Rivera, Jose R Lopez
8 Jan 2010
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Raquel Gonzalez Rivera, Jose R Lopez
8 Jan 2010
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Raquel Gonzalez Rivera, Jose R Lopez
Inspected site
MHMcNeil Healthcare LLC.Las Piedras, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | 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