Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-07.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2020 – 7 Feb 2020 | Human Drugs | 483 | On file |
| 28 May 2018 – 29 May 2018 | Human Drugs | 483 | View 483 → |
| 11 Dec 2017 – 13 Dec 2017 | Human Drugs | 483 | On file |
| 9 May 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2018
21 CFR 211.194(a)(8)
Second person sign off
Cited by Christopher R Czajka, Farhana Khan, Vioela J Caze
29 May 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Christopher R Czajka, Farhana Khan, Vioela J Caze
29 May 2018
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Christopher R Czajka, Farhana Khan, Vioela J Caze
29 May 2018
21 CFR 211.194(a)(4)
Complete Test Data
Cited by Christopher R Czajka, Farhana Khan, Vioela J Caze
29 May 2018
21 CFR 211.25(c)
Inadequate number of personnel
Cited by Christopher R Czajka, Farhana Khan, Vioela J Caze
Investigators
FDA investigators tied to this site in the record.
Xikui Chen1 insp.
Melkamu Getie Kebtie1 insp.
Christopher R Czajka1 insp.
Farhana Khan1 insp.
Vioela J Caze1 insp.
Himanshu Gupta1 insp.
Samina S Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SPS Pharma Services' 3 Form 483s
Verbatim observations 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