Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
5
Form 483s
1
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2024 – 26 Jul 2024 | Human Drugs | 483 | View 483 → |
| 12 Dec 2018 – 17 Dec 2018 | Human Drugs | Clean | |
| 3 Apr 2018 – 5 Apr 2018 | Human Drugs | Clean | |
| 11 Feb 2014 – 18 Feb 2014 | Human Drugs | Clean | |
| 16 Mar 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2024
21 CFR 211.130
Procedures are written, and followed
Cited by Tanya R Syffrard, Ruben C Quintana, Elena N Thomas, Divek R Jumani
26 Jul 2024
21 CFR 211.130
Procedures are written, and followed
Cited by Tanya R Syffrard, Ruben C Quintana, Elena N Thomas, Divek R Jumani
26 Jul 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tanya R Syffrard, Ruben C Quintana, Elena N Thomas, Divek R Jumani
26 Jul 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tanya R Syffrard, Ruben C Quintana, Elena N Thomas, Divek R Jumani
26 Jul 2024
21 CFR 211.67(b)(3)
Cleaning SOPs/instructions
Cited by Tanya R Syffrard, Ruben C Quintana, Elena N Thomas, Divek R Jumani
Investigators
FDA investigators tied to this site in the record.
Anita R Michael2 insp.
Tanya R Syffrard1 insp.
Ruben C Quintana1 insp.
Elena N Thomas1 insp.
Divek R Jumani1 insp.
Lisa B Orr1 insp.
Junho Pak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Altasciences CDMO Philadelphia's 1 Form 483
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat