Overview
- 10 public-safe observations are available for this inspection.
- 8 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.
29 Mar 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jorge L Lajara, Iraida Ortiz
29 Mar 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jorge L Lajara, Iraida Ortiz
29 Mar 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jorge L Lajara, Iraida Ortiz
29 Mar 2010
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jorge L Lajara, Iraida Ortiz
29 Mar 2010
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Jorge L Lajara, Iraida Ortiz
Inspected site
APAuro PR Inc.Caguas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 10 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