FDA Inspection
SPS Pharma ServicesSPS Pharma Services – FDA Inspection, May 29, 2018
Record Details
This FDA Inspection record concerns SPS Pharma Services, with an inspection on May 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christopher R. Czajka (FDA Associated Person)
- Farhana Khan (FDA Associated Person)
- Vioela Respress (Issuing Officer)
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ID · 1a757d09-f516-47d1-82bf-783b96eb59ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054398
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.25(c)Inadequate number of personnel
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Other FDA inspections of SPS Pharma Services
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2020 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 13, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for SPS Pharma Services
- FDA Inspection 1273753 - 2024-03-13
- FDA Inspection 1120458 - 2020-02-07
- FDA Inspection 1038741 - 2017-12-13
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