FDA Inspection
PAI Holdings, LLC, dba Pharmaceutical Associates, IncPAI Holdings, LLC, dba Pharmaceutical Associates, Inc – FDA Inspection, Sep 2, 2022
Record Details
This FDA Inspection record concerns PAI Holdings, LLC, dba Pharmaceutical Associates, Inc, with an inspection on September 2, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 2, 2022
- Product Type
- Drugs
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ID · 78bc7c00-9755-4a3b-b10c-16108f2be89b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1180090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 13, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
- FDA Inspection 1229199 - 2024-04-17
- FDA Inspection 1043040 - 2018-01-16
- FDA Inspection 1036787 - 2017-11-09
- FDA Inspection 995279 - 2016-12-13
- FDA Inspection 928826 - 2015-05-28
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