Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-22.
At a glance
Inspections
7
Form 483s
4
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 22 Aug 2025 | Human Drugs | 483 | View 483 → |
| 19 Jan 2022 – 3 Feb 2022 | Human Drugs | 483 | View 483 → |
| 4 Sep 2019 – 10 Sep 2019 | Human Drugs | Clean | |
| 27 Nov 2017 – 7 Dec 2017 | Human Drugs | 483 | View 483 → |
| 18 Jun 2015 – 25 Jun 2015 | Human Drugs | 483 | On file |
| 10 Jan 2013 | Not recorded | Clean | |
| 19 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2025
21 CFR 211.110(d)
Rejected in-process materials not quarantined
Cited by Pushpa S Jayasekara
3 Feb 2022
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Anastasia M Shields, Michele Gottshall, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Pushpa S Jayasekara1 insp.
Anastasia M Shields1 insp.
Michele Gottshall1 insp.
Brandy N Lepage1 insp.
Janet L Bowen1 insp.
Christina K Theodorou1 insp.
Gayle S Lawson1 insp.
Julianne C Mccullough1 insp.
Karyn M Campbell1 insp.
Denise M Digiulio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Almac Pharma Services LLC's 4 Form 483s
Source PDFs, 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